A Study of Avastin (Bevacizumab) in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Cancer, Initially Unresectable
Conditions
Ovarian Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carboplatin Type: Drug
Name: bevacizumab [Avastin] Type: Drug
Name: bevacizumab [Avastin] Type: Drug
Name: paclitaxel Type: Drug
Overall Status
Recruiting
Summary
This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant Avastin (bevacizumab) in patients with initially unresectable, FIGO stage IIIC/IV ovarian, tubal or peritoneal cancer. Patients will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without Avastin 15 mg/kg intravenously every 3 weeks in Cycles 1 to 3 before surgery. All patients will receive Avastin 15 mg/kg intravenously every 3 weeks for Cycles 6 to 26. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, for up to a maximum of 26 cycles.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Adult female patients, >/= 18 years of age

- Histologically confirmed and documented high risk stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma

- Patients are required to be deemed by a surgeon experienced in the management of ovarian cancer not to be eligible for primary complete debulking surgery during a laparoscopic procedure

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Life expectancy >/= 3 months

- Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards

- Patient should be beneficiary of healthcare coverage under the social security system

Exclusion Criteria:

- Non-epithelial ovarian cancer, ovarian tumour with low malignant potential, or mucinous and clear cell ovarian cancer

- Evidence of abdominal free air not explained by paracentesis or recent surgical procedure

- Previous systemic therapy for ovarian cancer

- Previous exposure to mouse CA-125 antibody

- Current or recent treatment (within 28 days prior to Day 1, Cycle 1) with another investigational drug or previous participation in this study

- Current or recent (within 10 days prior to first study drug dose) chronic daily treatment with aspirin (>325 mg/day)

- Planned intraperitoneal cytotoxic chemotherapy

- Inadequate bone marrow, liver or renal function

- History of myocardial infarction, unstable angina, stroke or ischemic attack within 6 months prior to Day 1, Cycle 1

- Uncontrolled hypertension

- Clinically significant (i.e. active) cardiovascular disease (e.g. NYHA Class II or greater congestive heart failure, aortic aneurism)

- Pre-existing peripheral neuropathy >/= CTC Grade 2

- Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell products or other recombinant humanized antibodies or to any planned chemotherapy

- Pregnant or lactating females

- History of other clinically active malignancy within 5 years of enrolment, except for tumours with a negligible risk for metastasis or death, such as adequately controlled basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast
Locations
Amiens, France
Status: Active, not recruiting
Besancon, France
Status: Recruiting
Bordeaux, France
Status: Active, not recruiting
Caen, France
Status: Active, not recruiting
Clermont Ferrand, France
Status: Active, not recruiting
Lille, France
Status: Recruiting
Marseille, France
Status: Active, not recruiting
Montpellier, France
Status: Active, not recruiting
Nice, France
Status: Active, not recruiting
Paris, France
Status: Active, not recruiting
Paris, France
Status: Active, not recruiting
Paris, France
Status: Active, not recruiting
St Cloud, France
Status: Active, not recruiting
Toulouse, France
Status: Completed
Villejuif, France
Status: Active, not recruiting
Start Date
February 2013
Completion Date
February 2017
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page