A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

• Conditions: EPITHELIAL OVARIAN CANCER FALLOPIAN TUBE CARCINOMA PRIMARY PERITONEAL CARCINOMA; MedDRA version: 14.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10052204Term: Ovarian carcinosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019525-34-IE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-11
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

- Female patients, >/=18 years of age
- Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Patients with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
- Life expectancy >/=3 months
- Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement. There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in whom initial surgical debulking was not appropriate will still be eligible providing
•the patient has a histological diagnosis and
•debulking surgery prior to disease progression is not foreseen
- Eligible for carboplatin (or cisplatin) and paclitaxel chemotherapy treatment in accordance with local standards of care following cytoreductive surgery. Patients who have received neo-adjuvant chemotherapy may be included. In such patients bevacizumab is started in addition to the post-surgical chemotherapy cycles.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 610
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

- Patients with non-epithelial ovarian cancer, ovarian tumors with low
malignant potential (i.e. borderline tumors), or synchronous primary endometrial carcinoma
- Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
- Planned intraperitoneal cytotoxic chemotherapy
- Radiotherapy within 28 days of Day 1, Cycle 1
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin or anticipation of the need for major surgery during the course of the study treatment (planned elective surgery).
- Inadequate bone marrow function/liver function/renal function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified