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 - ROSiA

• Conditions: EPITHELIAL OVARIAN CANCERFALLOPIAN TUBE CARCINOMAPRIMARY PERITONEAL CARCINOMA; MedDRA version: 12.1Level: LLTClassification code 10033128Term: Ovarian cancer; MedDRA version: 12.1Level: LLTClassification code 10052204Term: Ovarian carcinosarcoma; MedDRA version: 12.1Level: LLTClassification code 10016180Term: Fallopian tube cancer

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-30
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

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

Inclusion Criteria

•Histologically confirmed and documented high risk International Federation of Gynecologic Oncology (FIGO) Stage I–IIa (only if grade 3 / poorly differentiated) or Stage IIb–IV (any grade) epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or
Or
Histologically confirmed and documented clear cell carcinoma regardless of the FIGO stage (clear cell carcinoma is defined as either = 50% clear cell elements present or reported as clear cell carcinoma by the local pathologist).
Or
Histologically confirmed and documented carcinosarcoma.
Patients with recurrent ovarian cancer that have been previously treated with surgery alone for their early stage disease are eligible.

•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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with:
•non-epithelial ovarian cancer
•ovarian tumors with low malignant potential (i.e. borderline tumors)
•synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
ostage =Ia
ono more than superficial myometrial invasion
ono lymphovascular invasion
onot poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).
•Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy). Prior neo-adjuvant chemotherapy is allowed.
•Radiotherapy within 28 days of Day 1, Cycle 1. Patients may be given palliative radiotherapy to peripheral sites (e.g. bone metastasis) during this 28 day period but they must have recovered from any acute effects. Prior radiotherapy to any portion of the abdominal cavity or pelvis is not permitted.
•Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of bevacizumab.
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