Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer

NCT01970722Active, Not RecruitingPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

City of Hope Medical Center

Enrollment

40

Start Date

2014-05-19

Completion Date

2027-01-05

Study Type

INTERVENTIONAL

Official Title

Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin

Interventions

CarboplatinCisplatinGemcitabine HydrochlorideLaboratory Biomarker AnalysisPaclitaxelPegylated Liposomal Doxorubicin HydrochlorideQuality-of-Life AssessmentTherapeutic Conventional Surgery

Conditions

FIGO Stage IVA Ovarian CancerFIGO Stage IVB Ovarian CancerPlatinum-Resistant Ovarian CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Uterine Corpus CarcinomaStage III Fallopian Tube Cancer AJCC v7Stage III Ovarian Cancer AJCC v6 and v7Stage III Primary Peritoneal Cancer AJCC v7Stage III Uterine Corpus Cancer AJCC v7Stage IIIA Fallopian Tube Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v6 and v7Stage IIIA Primary Peritoneal Cancer AJCC v7Stage IIIA Uterine Corpus Cancer AJCC v7Stage IIIB Fallopian Tube Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v6 and v7Stage IIIB Primary Peritoneal Cancer AJCC v7Stage IIIB Uterine Corpus Cancer AJCC v7Stage IIIC Fallopian Tube Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v6 and v7Stage IIIC Primary Peritoneal Cancer AJCC v7Stage IIIC Uterine Corpus Cancer AJCC v7Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Primary Peritoneal Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7Stage IVA Uterine Corpus Cancer AJCC v7Stage IVB Uterine Corpus Cancer AJCC v7

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Provided informed consent
* Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
* Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 or Karnofsky scale (KPS) \>= 70%
* Patients who are platinum-sensitive or platinum resistant
* Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician
* For patients with newly diagnosed-ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following:

  * Decline in serum cancer antigen (CA) 125 level
  * At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
  * Improvement of ascites volume
  * Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery
  * Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =\< 1 and to baseline laboratory values as defined
* Hemoglobin (HGB) \>= 9 g/dL
* White blood cell (WBC) \>= 3,000/mcL
* Absolute neutrophil count (ANC) \>= 1,500/mcL
* Platelets (PLT) \>= 100,000/mcL
* Total bilirubin within normal institutional limits
* Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN)
* Creatinine \< 1.5 x ULN or creatinine clearance \> 60 ml/min according to Cockcroft-Gault formula
* Neuropathy (sensory and motor) NCI CTCAE grade =\< 2
* Prothrombin time (PT) such that international normalized ratio (INR) is \< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) \< 1.2 times control
* Serum albumin \>= 2.5
* No active infection requiring antibiotics
* Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
* Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
* Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia

Exclusion Criteria:

* Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
* Patients whose disease has progressed following at least 3 cycles of neoadjuvant chemotherapy as defined by at least one of the following:

  * Doubling of serum CA-125 level
  * At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
  * Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status)
* Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
* Patients whose circumstances do not permit completion of the study or the required follow-up
* Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy
* Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment)
* Metastatic non-gynecologic or breast primaries
* Sub-optimal resection as their surgical outcome
* Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer

Outcome Measures

Primary Outcomes

Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines

Toxicity for both primary and recurrent groups will be summarized using frequency tables.

Time frame: Up to 3 months post-surgery

Secondary Outcomes

Quality of life (QoL) assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire

The FACT-O has four subscales: physical, social/family, emotional, and functional well-being. Answers are on a scale of 0 'not at all' to 4 'very much'. To estimate effect sizes over time, generalized linear models will be used to estimate the correlations between potential prognostic factors. Generalized estimating equations (GEEs) have utility in modeling longitudinal effects across time in prospective cohorts, and the models will include time-dependent covariate structures for continuous outcomes. QoL will be compared to a historical control of intraperitoneal (IP) chemotherapy for women with ovarian cancer.

Time frame: Up to 15 months post-surgery

Progression-free survival (PFS)

PFS will be estimated in both groups. The survival curve will be estimated using Kaplan-Meier method and graphically displayed along with the corresponding 95% confidence curves. The Cox proportional hazards model will be used to derive an estimate of the hazard ratio and its corresponding 95% confidence limits.

Time frame: From time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by CA125 progression as defined by Gynecologic Cancer Intergroup Criteria (GCIG) or clinical symptoms or deterioration, assessed up to 3 years

Locations

City of Hope Corona, Corona, United States

City of Hope Medical Center, Duarte, United States

City of Hope Upland, Upland, United States

Parkview Hospital Randallia, Fort Wayne, United States

Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer