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: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 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-LT

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: • To assess the safety profile of bevacizumab when added to carboplatin and paclitaxel chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma.;Secondary Objective: • To assess the efficacy of bevacizumab as measured by: <br>- progression-free survival<br>- overall response rate: <br> - by RECIST and 50% CA-125 response criteria (responders”)<br> - by RECIST only (RECIST responders”)<br> - by 50% CA-125 response criteria only (CA-125 responders”) <br>- duration of response<br>- overall survival<br>- biological progression-free interval<br>;Primary end point(s): safety endpoint:<br>- The primary variable is the incidence rate of adverse events and rates for selected events with incidences less than 1%<br>- The rate of adverse events is defined as the proportion of patients from the safety population that experienced at least one, or a specific AE. <br>;Timepoint(s) of evaluation of this end point: 108 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Biological progression-free survival according to Response evaluation criteria in solid tumors (RECIST)<br>- Duration of response according to Response evaluation criteria in solid tumors (RECIST)<br>- Overall response rate according to Cancer antigen 125 criteria<br>- Overall response rate according to Response evaluation criteria in solid tumors (RECIST)<br>- Overall survival according to Response evaluation criteria in solid tumors (RECIST)<br>- Progression-free survival according to Response evaluation criteria in solid tumors (RECIST);Timepoint(s) of evaluation of this end point: 108 weeks

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