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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Carboplatin; Celecoxib

Criteria

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