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LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

NCT01015118CompletedPHASE3INTERVENTIONAL

Summary

The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.

Key Facts

Lead Sponsor

Boehringer Ingelheim

Enrollment

1366

Start Date

2009-11-17

Completion Date

2013-04-01

Study Type

INTERVENTIONAL

Official Title

Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Interventions

PlaceboPaclitaxelBIBF 1120CarboplatinPaclitaxelCarboplatin

Conditions

Ovarian NeoplasmsPeritoneal Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion criteria:

* first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
* International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV
* females, age 18 years or older
* life expectancy of at least 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* prior surgery, defined as either (a) debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in patients with stage IV disease for whom surgical debulking was not considered appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to disease progression (including interval debulking surgery)
* patient has given written informed consent which must be consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation
* planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery

Exclusion criteria:

* histologic diagnosis of a benign or borderline tumour or of a malignant tumour of non-epithelial origin of the ovary, the fallopian tube or the peritoneum
* planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery
* clinically relevant non-healing wound, ulcer or bone fracture
* clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration
* brain metastases
* pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher, except due to trauma
* history of major thromboembolic event
* known inherited or acquired bleeding disorder
* significant cardiovascular diseases
* clinically relevant pericardial effusion
* history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months
* inadequate safety laboratory values
* serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)
* poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy
* gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
* other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included if adequately treated: non-melanomatous skin cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk endometrial cancer
* prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy)
* prior systemic cytotoxic chemotherapy
* prior treatment with BIBF 1120 or any other angiogenesis inhibitor
* prior radiotherapy
* serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease or a laboratory abnormality that may increase the risk associated with study participation or study drug administration
* Women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy.
* pregnancy or breast feeding
* psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
* active alcohol or drug abuse
* patients unable to comply with the protocol
* any contraindications for therapy with paclitaxel or carboplatin
* treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial

Outcome Measures

Primary Outcomes

PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.

Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Time frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months

PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).

Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Time frame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months

Secondary Outcomes

PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).

Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Time frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months

PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).

Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Time frame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months

Overall Survival

Overall survival is defined as time from randomization to date of death (irrespective of reason). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Time frame: First drug administration to date of death until final DBL 26September16, upto 62 months

Time to CA-125 Tumour Marker Progression

Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 \>=2 x nadir in case nadir value \> Upper limit of normal (ULN) or CA-125 \>=2 x ULN in case nadir value \<= ULN.

Time frame: First drug administration until final DBL 26September16, upto 62 months

Objective Response Based on Investigator Assessment

Objective tumour response defined as either complete response \[CR\] or partial response \[PR\] in patients with at least 1 target lesion reported at baseline

Time frame: First drug administration until final DBL 26September16, upto 62 months

Change in Abdominal/Gastro-intestinal Symptoms Over Time

Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28). As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology). Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).

Time frame: First drug administration until final DBL 26September16, upto 62 months

Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.

Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure. As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning). Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).

Time frame: First drug administration until final DBL 26September16, upto 62 months

Locations

1199.15.10113 Boehringer Ingelheim Investigational Site, Tucson, United States

1199.15.10030 Boehringer Ingelheim Investigational Site, Long Beach, United States

1199.15.10001 Boehringer Ingelheim Investigational Site, Santa Rosa, United States

1199.15.10005 Boehringer Ingelheim Investigational Site, Englewood, United States

1199.15.10028 Boehringer Ingelheim Investigational Site, New Haven, United States

1199.15.10014 Boehringer Ingelheim Investigational Site, Orlando, United States

1199.15.10010 Boehringer Ingelheim Investigational Site, Augusta, United States

1199.15.10004 Boehringer Ingelheim Investigational Site, Savannah, United States

1199.15.10011 Boehringer Ingelheim Investigational Site, Louisville, United States

1199.15.10003 Boehringer Ingelheim Investigational Site, Marrero, United States

1199.15.10017 Boehringer Ingelheim Investigational Site, Detroit, United States

1199.15.10103 Boehringer Ingelheim Investigational Site, Minneapolis, United States

1199.15.10002 Boehringer Ingelheim Investigational Site, New York, United States

1199.15.10012 Boehringer Ingelheim Investigational Site, Charlotte, United States

1199.15.10020 Boehringer Ingelheim Investigational Site, Winston-Salem, United States

1199.15.10019 Boehringer Ingelheim Investigational Site, Bismarck, United States

1199.15.10024 Boehringer Ingelheim Investigational Site, Canton, United States

1199.15.10025 Boehringer Ingelheim Investigational Site, Cleveland, United States

1199.15.10029 Boehringer Ingelheim Investigational Site, Cleveland, United States

1199.15.10021 Boehringer Ingelheim Investigational Site, Portland, United States

1199.15.10013 Boehringer Ingelheim Investigational Site, Abington, United States

1199.15.10016 Boehringer Ingelheim Investigational Site, Allentown, United States

1199.15.10008 Boehringer Ingelheim Investigational Site, Providence, United States

1199.15.10102 Boehringer Ingelheim Investigational Site, Greenville, United States

1199.15.10006 Boehringer Ingelheim Investigational Site, Chattanooga, United States

1199.15.10104 Boehringer Ingelheim Investigational Site, Austin, United States

1199.15.10100 Boehringer Ingelheim Investigational Site, Bedford, United States

1199.15.10107 Boehringer Ingelheim Investigational Site, Dallas, United States

1199.15.10108 Boehringer Ingelheim Investigational Site, Dallas, United States

1199.15.10110 Boehringer Ingelheim Investigational Site, Fort Worth, United States

1199.15.10007 Boehringer Ingelheim Investigational Site, Houston, United States

1199.15.10105 Boehringer Ingelheim Investigational Site, Spokane, United States

1199.15.10112 Boehringer Ingelheim Investigational Site, Vancouver, United States

1199.15.61006 Boehringer Ingelheim Investigational Site, Camperdown, Australia

1199.15.61001 Boehringer Ingelheim Investigational Site, Waratah, Australia

1199.15.61004 Boehringer Ingelheim Investigational Site, Herston, Australia

1199.15.61003 Boehringer Ingelheim Investigational Site, Southe Brisbane, Australia

1199.15.61005 Boehringer Ingelheim Investigational Site, North Terrace, Australia

1199.15.61007 Boehringer Ingelheim Investigational Site, Parkville, Australia

1199.15.61002 Boehringer Ingelheim Investigational Site, Nedlands, Australia

1199.15.43003 Boehringer Ingelheim Investigational Site, Graz, Austria

1199.15.43001 Boehringer Ingelheim Investigational Site, Innsbruck, Austria

1199.15.43011 Boehringer Ingelheim Investigational Site, Krems, Austria

1199.15.43007 Boehringer Ingelheim Investigational Site, Kufstein, Austria

1199.15.43005 Boehringer Ingelheim Investigational Site, Linz, Austria

1199.15.43010 Boehringer Ingelheim Investigational Site, Salzburg, Austria

1199.15.43002 Boehringer Ingelheim Investigational Site, Vienna, Austria

1199.15.43012 Boehringer Ingelheim Investigational Site, Vienna, Austria

1199.15.43013 Boehringer Ingelheim Investigational Site, Wels, Austria

1199.15.32010 Boehringer Ingelheim Investigational Site, Edegem, Belgium

1199.15.32012 Boehringer Ingelheim Investigational Site, Hasselt, Belgium

1199.15.32003 Boehringer Ingelheim Investigational Site, La Louvière, Belgium

1199.15.32001 Boehringer Ingelheim Investigational Site, Leuven, Belgium

1199.15.32007 Boehringer Ingelheim Investigational Site, Liège, Belgium

1199.15.32008 Boehringer Ingelheim Investigational Site, Sint-Niklaas, Belgium

1199.15.11005 Boehringer Ingelheim Investigational Site, Vancouver, Canada

1199.15.11004 Boehringer Ingelheim Investigational Site, Hamilton, Canada

1199.15.11008 Boehringer Ingelheim Investigational Site, London, Canada

1199.15.11009 Boehringer Ingelheim Investigational Site, Toronto, Canada

1199.15.11003 Boehringer Ingelheim Investigational Site, Montreal, Canada

1199.15.11006 Boehringer Ingelheim Investigational Site, Montreal, Canada

1199.15.11001 Boehringer Ingelheim Investigational Site, Sherbrooke, Canada

1199.15.42002 Boehringer Ingelheim Investigational Site, Brno, Czechia

1199.15.42003 Boehringer Ingelheim Investigational Site, Olomouc, Czechia

1199.15.42001 Boehringer Ingelheim Investigational Site, Prague, Czechia

1199.15.45004 Boehringer Ingelheim Investigational Site, Aalborg, Denmark

1199.15.45002 Boehringer Ingelheim Investigational Site, Herlev, Denmark

1199.15.45005 Boehringer Ingelheim Investigational Site, Herning, Denmark

1199.15.45001 Boehringer Ingelheim Investigational Site, Købenahvn Ø, Denmark

1199.15.45003 Boehringer Ingelheim Investigational Site, Odense C, Denmark

1199.15.35801 Boehringer Ingelheim Investigational Site, Helsinki, Finland

1199.15.35804 Boehringer Ingelheim Investigational Site, Jyväskylä, Finland

1199.15.35805 Boehringer Ingelheim Investigational Site, Kuopio, Finland

1199.15.35803 Boehringer Ingelheim Investigational Site, Oulu, Finland

1199.15.35802 Boehringer Ingelheim Investigational Site, Tampere, Finland

1199.15.33047 Boehringer Ingelheim Investigational Site, Aix-en-Provence, France

1199.15.33035 Boehringer Ingelheim Investigational Site, Avignon, France

1199.15.33055 Boehringer Ingelheim Investigational Site, Besançon, France

1199.15.33003 Boehringer Ingelheim Investigational Site, Bordeaux, France

1199.15.33004 Boehringer Ingelheim Investigational Site, Bordeaux, France

1199.15.33006 Boehringer Ingelheim Investigational Site, Caen, France

1199.15.33025 Boehringer Ingelheim Investigational Site, Clermont-Ferrand, France

1199.15.33048 Boehringer Ingelheim Investigational Site, Dechy, France

1199.15.33042 Boehringer Ingelheim Investigational Site, Fréjus, France

1199.15.33037 Boehringer Ingelheim Investigational Site, La Roche-sur-Yon, France

1199.15.33008 Boehringer Ingelheim Investigational Site, Le Mans, France

1199.15.33009 Boehringer Ingelheim Investigational Site, Lille, France

1199.15.33020 Boehringer Ingelheim Investigational Site, Lyon, France

1199.15.33011 Boehringer Ingelheim Investigational Site, Marseille, France

1199.15.33021 Boehringer Ingelheim Investigational Site, Monaco Cedex, France

1199.15.33012 Boehringer Ingelheim Investigational Site, Mont-de-Marsan, France

1199.15.33052 Boehringer Ingelheim Investigational Site, Montpellier, France

1199.15.33053 Boehringer Ingelheim Investigational Site, Mougins, France

1199.15.33038 Boehringer Ingelheim Investigational Site, Nancy, France

1199.15.33013 Boehringer Ingelheim Investigational Site, Nantes, France

1199.15.33015 Boehringer Ingelheim Investigational Site, Orléans, France

1199.15.33001 Boehringer Ingelheim Investigational Site, Paris, France

1199.15.33027 Boehringer Ingelheim Investigational Site, Paris, France

1199.15.33051 Boehringer Ingelheim Investigational Site, Périgueux, France

1199.15.33030 Boehringer Ingelheim Investigational Site, Plerin SUR MER, France

1199.15.33045 Boehringer Ingelheim Investigational Site, Saint-Cloud, France

1199.15.33033 Boehringer Ingelheim Investigational Site, Saint-Herblain, France

1199.15.33018 Boehringer Ingelheim Investigational Site, Strasbourg, France

1199.15.33039 Boehringer Ingelheim Investigational Site, Thonon-les-Bains, France

1199.15.33031 Boehringer Ingelheim Investigational Site, Vandœuvre-lès-Nancy, France

1199.15.33050 Boehringer Ingelheim Investigational Site, Villejuif, France

1199.15.49040 Boehringer Ingelheim Investigational Site, Aachen, Germany

1199.15.49070 Boehringer Ingelheim Investigational Site, Aalen, Germany

1199.15.49086 Boehringer Ingelheim Investigational Site, Aschaffenburg, Germany

1199.15.49002 Boehringer Ingelheim Investigational Site, Berlin, Germany

1199.15.49039 Boehringer Ingelheim Investigational Site, Berlin, Germany

1199.15.49041 Boehringer Ingelheim Investigational Site, Berlin, Germany

1199.15.49004 Boehringer Ingelheim Investigational Site, Bonn, Germany

1199.15.49042 Boehringer Ingelheim Investigational Site, Bonn, Germany

1199.15.49071 Boehringer Ingelheim Investigational Site, Bottrop, Germany

1199.15.49081 Boehringer Ingelheim Investigational Site, Böblingen, Germany

1199.15.49043 Boehringer Ingelheim Investigational Site, Chemnitz, Germany

1199.15.49005 Boehringer Ingelheim Investigational Site, Dessau, Germany

1199.15.49006 Boehringer Ingelheim Investigational Site, Detmold, Germany

1199.15.49007 Boehringer Ingelheim Investigational Site, Dresden, Germany

1199.15.49067 Boehringer Ingelheim Investigational Site, Dresden, Germany

1199.15.49008 Boehringer Ingelheim Investigational Site, Düsseldorf, Germany

1199.15.49009 Boehringer Ingelheim Investigational Site, Ebersberg, Germany

1199.15.49010 Boehringer Ingelheim Investigational Site, Essen, Germany

1199.15.49066 Boehringer Ingelheim Investigational Site, Essen, Germany

1199.15.49089 Boehringer Ingelheim Investigational Site, Essen, Germany

1199.15.49045 Boehringer Ingelheim Investigational Site, Frankfurt, Germany

1199.15.49011 Boehringer Ingelheim Investigational Site, Freiburg im Breisgau, Germany

1199.15.49068 Boehringer Ingelheim Investigational Site, Freiburg im Breisgau, Germany

1199.15.49083 Boehringer Ingelheim Investigational Site, Freudenstadt, Germany

1199.15.49046 Boehringer Ingelheim Investigational Site, Fulda, Germany

1199.15.49012 Boehringer Ingelheim Investigational Site, Fürstenfeldbruck, Germany

1199.15.49064 Boehringer Ingelheim Investigational Site, Greifswald, Germany

1199.15.49076 Boehringer Ingelheim Investigational Site, Gütersloh, Germany

1199.15.49014 Boehringer Ingelheim Investigational Site, Halle/S., Germany

1199.15.49015 Boehringer Ingelheim Investigational Site, Hamburg, Germany

1199.15.49084 Boehringer Ingelheim Investigational Site, Hamburg, Germany

1199.15.49073 Boehringer Ingelheim Investigational Site, Hanau, Germany

1199.15.49095 Boehringer Ingelheim Investigational Site, Heidelberg, Germany

1199.15.49080 Boehringer Ingelheim Investigational Site, Henstedt-Ulzburg, Germany

1199.15.49047 Boehringer Ingelheim Investigational Site, Hildesheim, Germany

1199.15.49016 Boehringer Ingelheim Investigational Site, Karlsruhe, Germany

1199.15.49017 Boehringer Ingelheim Investigational Site, Kiel, Germany

1199.15.49062 Boehringer Ingelheim Investigational Site, Krefeld, Germany

1199.15.49018 Boehringer Ingelheim Investigational Site, Landshut, Germany

1199.15.49087 Boehringer Ingelheim Investigational Site, Ludwigsburg, Germany

1199.15.49019 Boehringer Ingelheim Investigational Site, Lübeck, Germany

1199.15.49020 Boehringer Ingelheim Investigational Site, Magdeburg, Germany

1199.15.49021 Boehringer Ingelheim Investigational Site, Mainz, Germany

1199.15.49022 Boehringer Ingelheim Investigational Site, Mainz, Germany

1199.15.49023 Boehringer Ingelheim Investigational Site, Mannheim, Germany

1199.15.49024 Boehringer Ingelheim Investigational Site, Marburg, Germany

1199.15.49025 Boehringer Ingelheim Investigational Site, München, Germany

1199.15.49026 Boehringer Ingelheim Investigational Site, München, Germany

1199.15.49027 Boehringer Ingelheim Investigational Site, München, Germany

1199.15.49048 Boehringer Ingelheim Investigational Site, München, Germany

1199.15.49065 Boehringer Ingelheim Investigational Site, Neumarkt in der Oberpfalz, Germany

1199.15.49029 Boehringer Ingelheim Investigational Site, Offenbach, Germany

1199.15.49082 Boehringer Ingelheim Investigational Site, Paderborn, Germany

1199.15.49030 Boehringer Ingelheim Investigational Site, Radebeul, Germany

1199.15.49061 Boehringer Ingelheim Investigational Site, Ravensburg, Germany

1199.15.49050 Boehringer Ingelheim Investigational Site, Regensburg, Germany

1199.15.49051 Boehringer Ingelheim Investigational Site, Rosenheim, Germany

1199.15.49052 Boehringer Ingelheim Investigational Site, Rostock, Germany

1199.15.49054 Boehringer Ingelheim Investigational Site, Saalfeld, Germany

1199.15.49031 Boehringer Ingelheim Investigational Site, Salzgitter, Germany

1199.15.49055 Boehringer Ingelheim Investigational Site, Solingen, Germany

1199.15.49092 Boehringer Ingelheim Investigational Site, Stadthagen, Germany

1199.15.49063 Boehringer Ingelheim Investigational Site, Stendal, Germany

1199.15.49093 Boehringer Ingelheim Investigational Site, Stralsund, Germany

1199.15.49033 Boehringer Ingelheim Investigational Site, Stuttgart, Germany

1199.15.49056 Boehringer Ingelheim Investigational Site, Stuttgart, Germany

1199.15.49090 Boehringer Ingelheim Investigational Site, Stuttgart, Germany

1199.15.49079 Boehringer Ingelheim Investigational Site, Suhl, Germany

1199.15.49034 Boehringer Ingelheim Investigational Site, Traunstein, Germany

1199.15.49057 Boehringer Ingelheim Investigational Site, Trier, Germany

1199.15.49035 Boehringer Ingelheim Investigational Site, Tübingen, Germany

1199.15.49058 Boehringer Ingelheim Investigational Site, Ulm, Germany

1199.15.49085 Boehringer Ingelheim Investigational Site, Viersen, Germany

1199.15.49001 Boehringer Ingelheim Investigational Site, Wiesbaden, Germany

1199.15.49036 Boehringer Ingelheim Investigational Site, Wiesbaden, Germany

1199.15.49059 Boehringer Ingelheim Investigational Site, Witten, Germany

1199.15.49037 Boehringer Ingelheim Investigational Site, Wolfsburg, Germany

1199.15.49060 Boehringer Ingelheim Investigational Site, Worms, Germany

1199.15.30001 Boehringer Ingelheim Investigational Site, Athens, Greece

1199.15.30003 Boehringer Ingelheim Investigational Site, Heraklio, Greece

1199.15.30002 Boehringer Ingelheim Investigational Site, Nea Kifissia, Greece

1199.15.30005 Boehringer Ingelheim Investigational Site, Pátrai, Greece

1199.15.30004 Boehringer Ingelheim Investigational Site, Thessaloniki, Greece

1199.15.39027 Boehringer Ingelheim Investigational Site, Asti, Italy

1199.15.39002 Boehringer Ingelheim Investigational Site, Avellino, Italy

1199.15.39003 Boehringer Ingelheim Investigational Site, Aviano (PN), Italy

1199.15.39004 Boehringer Ingelheim Investigational Site, Bari, Italy

1199.15.39005 Boehringer Ingelheim Investigational Site, Benevento, Italy

1199.15.39029 Boehringer Ingelheim Investigational Site, Brescia, Italy

1199.15.39040 Boehringer Ingelheim Investigational Site, Catania, Italy

1199.15.39007 Boehringer Ingelheim Investigational Site, Catanzaro, Italy

1199.15.39008 Boehringer Ingelheim Investigational Site, Faenza (RA), Italy

1199.15.39039 Boehringer Ingelheim Investigational Site, Ferrara, Italy

1199.15.39017 Boehringer Ingelheim Investigational Site, Genova, Italy

1199.15.39037 Boehringer Ingelheim Investigational Site, Lecce, Italy

1199.15.39009 Boehringer Ingelheim Investigational Site, Mantova, Italy

1199.15.39033 Boehringer Ingelheim Investigational Site, Meldola (FC), Italy

1199.15.39021 Boehringer Ingelheim Investigational Site, Milan, Italy

1199.15.39028 Boehringer Ingelheim Investigational Site, Milan, Italy

1199.15.39036 Boehringer Ingelheim Investigational Site, Milan, Italy

1199.15.39010 Boehringer Ingelheim Investigational Site, Modena, Italy

1199.15.39026 Boehringer Ingelheim Investigational Site, Monza, Italy

1199.15.39001 Boehringer Ingelheim Investigational Site, Naples, Italy

1199.15.39022 Boehringer Ingelheim Investigational Site, Padua, Italy

1199.15.39011 Boehringer Ingelheim Investigational Site, Palermo, Italy

1199.15.39031 Boehringer Ingelheim Investigational Site, Palermo, Italy

1199.15.39023 Boehringer Ingelheim Investigational Site, Pisa, Italy

1199.15.39012 Boehringer Ingelheim Investigational Site, Pordenone, Italy

1199.15.39024 Boehringer Ingelheim Investigational Site, Reggio Emilia, Italy

1199.15.39013 Boehringer Ingelheim Investigational Site, Roma, Italy

1199.15.39014 Boehringer Ingelheim Investigational Site, Roma, Italy

1199.15.39034 Boehringer Ingelheim Investigational Site, Rozzano (MI), Italy

1199.15.39030 Boehringer Ingelheim Investigational Site, San Fermo della Battaglia, Italy

1199.15.39018 Boehringer Ingelheim Investigational Site, Sondrio, Italy

1199.15.39006 Boehringer Ingelheim Investigational Site, Tappino (CB), Italy

1199.15.39019 Boehringer Ingelheim Investigational Site, Torino, Italy

1199.15.39020 Boehringer Ingelheim Investigational Site, Torino, Italy

1199.15.39032 Boehringer Ingelheim Investigational Site, Varese, Italy

1199.15.31009 Boehringer Ingelheim Investigational Site, 's-Hertogenbosch, Netherlands

1199.15.31005 Boehringer Ingelheim Investigational Site, Amersfoort, Netherlands

1199.15.31004 Boehringer Ingelheim Investigational Site, Niewegein, Netherlands

1199.15.31003 Boehringer Ingelheim Investigational Site, Nijmegen, Netherlands

1199.15.31006 Boehringer Ingelheim Investigational Site, Rotterdam, Netherlands

1199.15.31002 Boehringer Ingelheim Investigational Site, Utrecht, Netherlands

1199.15.47003 Boehringer Ingelheim Investigational Site, Bergen, Norway

1199.15.47001 Boehringer Ingelheim Investigational Site, Oslo, Norway

1199.15.47002 Boehringer Ingelheim Investigational Site, Stavanger, Norway

1199.15.47004 Boehringer Ingelheim Investigational Site, Trondheim, Norway

1199.15.48003 Boehringer Ingelheim Investigational Site, Gdansk, Poland

1199.15.48006 Boehringer Ingelheim Investigational Site, Lublin, Poland

1199.15.48001 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1199.15.35102 Boehringer Ingelheim Investigational Site, Coimbra, Portugal

1199.15.35104 Boehringer Ingelheim Investigational Site, Coimbra, Portugal

1199.15.35101 Instituto Portugues de Oncologia Lisboa Francisco Gentil, Lisbon, Portugal

1199.15.35106 Boehringer Ingelheim Investigational Site, Lisbon, Portugal

1199.15.35108 Boehringer Ingelheim Investigational Site, Lisbon, Portugal

1199.15.35105 Boehringer Ingelheim Investigational Site, Porto, Portugal

1199.15.35109 Boehringer Ingelheim Investigational Site, Vila Real, Portugal

1199.15.70006 Boehringer Ingelheim Investigational Site, Barnaul, Russia

1199.15.70007 Boehringer Ingelheim Investigational Site, Kazan', Russia

1199.15.70001 Boehringer Ingelheim Investigational Site, Moscow, Russia

1199.15.70002 Boehringer Ingelheim Investigational Site, Saint Petersburg, Russia

1199.15.70005 Boehringer Ingelheim Investigational Site, Yekaterinburg, Russia

1199.15.42101 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1199.15.42105 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1199.15.42106 Boehringer Ingelheim Investigational Site, Košice, Slovakia

1199.15.42103 Boehringer Ingelheim Investigational Site, Nitra, Slovakia

1199.15.42104 Boehringer Ingelheim Investigational Site, Poprad, Slovakia

1199.15.42102 Boehringer Ingelheim Investigational Site, Žilina, Slovakia

1199.15.34001 Boehringer Ingelheim Investigational Site, Badalona, Spain

1199.15.34003 Boehringer Ingelheim Investigational Site, Barcelona, Spain

1199.15.34006 Boehringer Ingelheim Investigational Site, Girona, Spain

1199.15.34004 Boehringer Ingelheim Investigational Site, Lleida, Spain

1199.15.34002 Boehringer Ingelheim Investigational Site, Madrid, Spain

1199.15.34010 Boehringer Ingelheim Investigational Site, Madrid, Spain

1199.15.34005 Boehringer Ingelheim Investigational Site, Palma de Mallorca, Spain

1199.15.34009 Boehringer Ingelheim Investigational Site, Valencia, Spain

1199.15.46005 Boehringer Ingelheim Investigational Site, Linköping, Sweden

1199.15.46001 Boehringer Ingelheim Investigational Site, Lund, Sweden

1199.15.46002 Boehringer Ingelheim Investigational Site, Stockholm, Sweden

1199.15.46004 Boehringer Ingelheim Investigational Site, Umeå, Sweden

1199.15.46003 Boehringer Ingelheim Investigational Site, Uppsala, Sweden

1199.15.38006 Boehringer Ingelheim Investigational Site, Cherkasy, Ukraine

1199.15.38005 Boehringer Ingelheim Investigational Site, Dnipro, Ukraine

1199.15.38004 Boehringer Ingelheim Investigational Site, Donetsk, Ukraine

1199.15.38002 Boehringer Ingelheim Investigational Site, Kharkiv, Ukraine

1199.15.38003 Boehringer Ingelheim Investigational Site, Lviv, Ukraine

1199.15.44006 Boehringer Ingelheim Investigational Site, Derby, United Kingdom

1199.15.44007 Boehringer Ingelheim Investigational Site, Dundee, United Kingdom

1199.15.44003 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom

1199.15.44001 Boehringer Ingelheim Investigational Site, Guildford, United Kingdom

1199.15.44005 Boehringer Ingelheim Investigational Site, London, United Kingdom

1199.15.44004 Boehringer Ingelheim Investigational Site, Nottingham, United Kingdom

1199.15.44002 Boehringer Ingelheim Investigational Site, Poole, United Kingdom

1199.15.44008 Boehringer Ingelheim Investigational Site, Truro, United Kingdom

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Linked Papers

2023-04-18

Angiogenesis inhibitors for the treatment of epithelial ovarian cancer

Many women, and other females, with epithelial ovarian cancer (EOC) develop resistance to conventional chemotherapy drugs. Drugs that inhibit angiogenesis (development of new blood vessels), essential for tumour growth, control cancer growth by denying blood supply to tumour nodules. To compare the effectiveness and toxicities of angiogenesis inhibitors for treatment of epithelial ovarian cancer (EOC). We identified randomised controlled trials (RCTs) by searching CENTRAL, MEDLINE and Embase (from 1990 to 30 September 2022). We searched clinical trials registers and contacted investigators of completed and ongoing trials for further information. RCTs comparing angiogenesis inhibitors with standard chemotherapy, other types of anti-cancer treatment, other angiogenesis inhibitors with or without other treatments, or placebo/no treatment in a maintenance setting, in women with EOC. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our outcomes were overall survival (OS), progression-free survival (PFS), quality of life (QoL), adverse events (grade 3 and above) and hypertension (grade 2 and above). We identified 50 studies (14,836 participants) for inclusion (including five studies from the previous version of this review): 13 solely in females with newly-diagnosed EOC and 37 in females with recurrent EOC (nine studies in platinum-sensitive EOC; 19 in platinum-resistant EOC; nine with studies with mixed or unclear platinum sensitivity). The main results are presented below. Newly-diagnosed EOC Bevacizumab, a monoclonal antibody that binds vascular endothelial growth factor (VEGF), given with chemotherapy and continued as maintenance, likely results in little to no difference in OS compared to chemotherapy alone (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.88 to 1.07; 2 studies, 2776 participants; moderate-certainty evidence). Evidence is very uncertain for PFS (HR 0.82, 95% CI 0.64 to 1.05; 2 studies, 2746 participants; very low-certainty evidence), although the combination results in a slight reduction in global QoL (mean difference (MD) -6.4, 95% CI -8.86 to -3.94; 1 study, 890 participants; high-certainty evidence). The combination likely increases any adverse event (grade ≥ 3) (risk ratio (RR) 1.16, 95% CI 1.07 to 1.26; 1 study, 1485 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 2) (RR 4.27, 95% CI 3.25 to 5.60; 2 studies, 2707 participants; low-certainty evidence). Tyrosine kinase inhibitors (TKIs) to block VEGF receptors (VEGF-R), given with chemotherapy and continued as maintenance, likely result in little to no difference in OS (HR 0.99, 95% CI 0.84 to 1.17; 2 studies, 1451 participants; moderate-certainty evidence) and likely increase PFS slightly (HR 0.88, 95% CI 0.77 to 1.00; 2 studies, 2466 participants; moderate-certainty evidence). The combination likely reduces QoL slightly (MD -1.86, 95% CI -3.46 to -0.26; 1 study, 1340 participants; moderate-certainty evidence), but it increases any adverse event (grade ≥ 3) slightly (RR 1.31, 95% CI 1.11 to 1.55; 1 study, 188 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 3) (RR 6.49, 95% CI 2.02 to 20.87; 1 study, 1352 participants; low-certainty evidence). Recurrent EOC (platinum-sensitive) Moderate-certainty evidence from three studies (with 1564 participants) indicates that bevacizumab with chemotherapy, and continued as maintenance, likely results in little to no difference in OS (HR 0.90, 95% CI 0.79 to 1.02), but likely improves PFS (HR 0.56, 95% CI 0.50 to 0.63) compared to chemotherapy alone. The combination may result in little to no difference in QoL (MD 0.8, 95% CI -2.11 to 3.71; 1 study, 486 participants; low-certainty evidence), but it increases the rate of any adverse event (grade ≥ 3) slightly (RR 1.11, 1.07 to 1.16; 3 studies, 1538 participants; high-certainty evidence). Hypertension (grade ≥ 3) was more common in arms with bevacizumab (RR 5.82, 95% CI 3.84 to 8.83; 3 studies, 1538 participants). TKIs with chemotherapy may result in little to no difference in OS (HR 0.86, 95% CI 0.67 to 1.11; 1 study, 282 participants; low-certainty evidence), likely increase PFS (HR 0.56, 95% CI 0.44 to 0.72; 1 study, 282 participants; moderate-certainty evidence), and may have little to no effect on QoL (MD 6.1, 95% CI -0.96 to 13.16; 1 study, 146 participants; low-certainty evidence). Hypertension (grade ≥ 3) was more common with TKIs (RR 3.32, 95% CI 1.21 to 9.10). Recurrent EOC (platinum-resistant) Bevacizumab with chemotherapy and continued as maintenance increases OS (HR 0.73, 95% CI 0.61 to 0.88; 5 studies, 778 participants; high-certainty evidence) and likely results in a large increase in PFS (HR 0.49, 95% CI 0.42 to 0.58; 5 studies, 778 participants; moderate-certainty evidence). The combination may result in a large increase in hypertension (grade ≥ 2) (RR 3.11, 95% CI 1.83 to 5.27; 2 studies, 436 participants; low-certainty evidence). The rate of bowel fistula/perforation (grade ≥ 2) may be slightly higher with bevacizumab (RR 6.89, 95% CI 0.86 to 55.09; 2 studies, 436 participants). Evidence from eight studies suggest TKIs with chemotherapy likely result in little to no difference in OS (HR 0.85, 95% CI 0.68 to 1.08; 940 participants; moderate-certainty evidence), with low-certainty evidence that it may increase PFS (HR 0.70, 95% CI 0.55 to 0.89; 940 participants), and may result in little to no meaningful difference in QoL (MD ranged from -0.19 at 6 weeks to -3.40 at 4 months). The combination increases any adverse event (grade ≥ 3) slightly (RR 1.23, 95% CI 1.02 to 1.49; 3 studies, 402 participants; high-certainty evidence). The effect on bowel fistula/perforation rates is uncertain (RR 2.74, 95% CI 0.77 to 9.75; 5 studies, 557 participants; very low-certainty evidence). Bevacizumab likely improves both OS and PFS in platinum-resistant relapsed EOC. In platinum-sensitive relapsed disease, bevacizumab and TKIs probably improve PFS, but may or may not improve OS. The results for TKIs in platinum-resistant relapsed EOC are similar. The effects on OS or PFS in newly-diagnosed EOC are less certain, with a decrease in QoL and increase in adverse events. Overall adverse events and QoL data were more variably reported than were PFS data. There appears to be a role for anti-angiogenesis treatment, but given the additional treatment burden and economic costs of maintenance treatments, benefits and risks of anti-angiogenesis treatments should be carefully considered.