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: 17.0Level: LLTClassification code 10052204Term: Ovarian carcinosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Last Update Posted: 7 December 2015

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
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
- History or evidence of NCI CTCAE Grade =1 arterial thromboembolic event or Grade =3 venous thromboembolic event within the 6 months prior to enrolment

Study & Design

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