CompletedPhase 2

A Study of Bevacizumab (Avastin) in Neoadjuvant Therapy in Participants With International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC/IV Ovarian, Tubal, or Peritoneal Cancer, Initially Unresectable

France99 participantsStarted 2013-02-01

Plain-language summary

This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery \[IDS\]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed and documented high-risk FIGO stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma * Not eligible for primary complete debulking surgery during a laparoscopic procedure as judged by a surgeon experienced in management of ovarian cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Life expectancy greater than or equal to (\>/=) 3 months * Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards * Beneficiaries of healthcare coverage under the social security system Exclusion Criteria: * Non-epithelial ovarian cancer, ovarian tumor with low malignant potential, mucinous and clear cell ovarian cancer, or carcinosarcoma * 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 (within 28 days prior to Day 1 of Cycle 1) treatment 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 greater than (\>) 325 milligrams (mg) per day * Planned intraperitoneal cytotoxic chemotherapy * Inadequate bone marrow, liver, or renal function * History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to Day 1 of Cycle 1 *…

What they're measuring

Percentage of Participants with Complete Resection After IDS

Timeframe: After IDS (approximately 4 months from randomization)

Percentage of Participants with Different CC Scores After IDS

Timeframe: After IDS (approximately 4 months from randomization)

Trial details

NCT IDNCT01739218

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08-17