GLOBAL STUDY TO ASSESS THE ADDITION OF BEVACIZUMAB TO CARBOPLATIN AND PACLITAXEL AS FRONT-LINE TREATMENT OF EPITHELIAL OVARIAN CANCER, FALLOPIAN TUBE CARCINOMA OR PRIMARY PERITONEAL CARCINOMA

Phase 3

Recruiting

• Conditions: ovariancancer; ovariancarcinoma; 10038594; 10033283

• Registration Number: NL-OMON39830
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Zie pagina 39 van het protocol MO22923 versie 2, 26 Mei 2011</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Zie pagina 39 van het protocol MO22923 versie 2, 26 Mei 2011</p><br>