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Study of the Combination Carboplatin Plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients

NCT01124435CompletedPHASE2INTERVENTIONAL

Summary

The aim of this study is to evaluate the antitumor activity and potential adverse effects of the combination celecoxib plus carboplatin in patients with recurrent, heavily pre-treated Ovarian Cancer (OC). The potential changes induced by the experimental combination on angiogenesis-related serum markers and quality of life measures will be also evaluated.The main objective is to evaluate the response rate. Secondary objectives are the following:toxicity;progression free survival;overall survival;duration of response;quality of life;modulation of angiogenesis-related molecules.

Key Facts

Lead Sponsor

Catholic University of the Sacred Heart

Enrollment

Start Date

2003-10-01

Completion Date

2007-09-01

Study Type

INTERVENTIONAL

Official Title

Phase II Study of the Combination Carboplatin Plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients

Interventions

Carboplatin plus Celecoxib

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

* Recurrent epithelial ovarian or fallopian tube or peritoneal serous carcinomas with measurable disease as assessed by Response Evaluation Criteria in Solid Tumors criteria
* Patients will require to have received a platinum-containing regimen as primary treatment and at least one line of chemotherapy for recurrent disease
* An interval time from the last platinum-based chemotherapy after 6months
* 18 years of years
* Eastern Cooperative Oncology Group performance status of 0 to 2
* Adequate bone marrow
* Adequate renal and hepatic functions
* Written informed consent to the study protocol

Exclusion Criteria:

* Hypersensitivity to celecoxib or aspirin or other nonsteroidal anti-inflammatory drugs or sulfonamides
* Significant comorbidities including any active coronary artery disease requiring management or symptomatic congestive heart failure or bleeding diathesis or uncontrolled severe hypertension or active gastrointestinal ulcer within 12 months or chronic inflammatory bowel diseases or deep venous or arterial thrombosis within 12 months or history of pulmonary embolism
* Concomitant use of possible interactive drugs
* Surgery and chemotherapy or radiotherapy within 1 month
* Actual or potential childbearing
* Breast-feeding
* Prior cancer treatment with a COX2 inhibitor
* Any psychological and/or sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Outcome Measures

Primary Outcomes

Efficacy of the Combination Carboplatin plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients

The tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and duration of response, progression-free survival (PFS), overall survival (OS), toxicity assessment, and quality of life (QoL) measures with carboplatin-celcoxib in heavly pretreated recurrent ovarian cancer patients.

Time frame: 48 months

Secondary Outcomes

The modulation of angiogenesis-related molecules with the combination celecoxib plus carboplatin in patients with recurrent, heavily pre-treated OC

Serum levels of vascular endothelial growth factor (VEGF) and endostatin evaluated in a preliminary series of 11 patients at baseline and after 1 month of carboplatin-celecoxib

Time frame: 12 months

Locations

Department of Obstetrics and Gynecology,Catholic University, Rome, Italy, Rome, Italy

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.