Study assessing the efficacy and the safety of bevacizumab in association with a standard chemotherapy before surgery of ovarian cancer

Phase 1

• Conditions: Epithelial ovarian cancerFallopian tube carcinomaPrimary peritoneal carcinoma; MedDRA version: 20.0Level: LLTClassification code 10052204Term: Ovarian carcinosarcomaSystem Organ Class: 100000021045; MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: 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: EUCTR2012-001144-22-FR
• Lead Sponsor: ROCHE SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-03
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Written, informed consent obtained prior to any study-specific procedure
- Woman aged = 18 years
- Histologically confirmed and documented, by peritoneal biopsy, high risk epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
- Patients are required to be deemed by a surgeron experienced in the management of ovarian cancer not to be eligible for primary complete debulking surgery during a laparoscopic procedure.
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

* Patient with:
• non-epithelial ovarian cancer
• ovarian tumour with low malignant potential (i.e. borderline tumour)
• inadequate bone marrow, liver or renal function
• Carcinosarcoma

* Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy)

* Planned intraperitoneal cytotoxic chemotherapy

Study & Design

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