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

Sponsor
Hoffmann-La Roche
Study ID
NCT01739218
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Carboplatin will be administered at a dose calculated according to the Calvert formula (\[participant's glomerular filtration rate + 25\] multiplied by the target area under the concentration-time curve \[AUC\] of 5 milligrams per milliliter per minute \[mg/mL/min\]), as intravenous \[IV\] infusion over 30-60 minutes \[min\] every 3 weeks).
  • Paclitaxel — DRUG
    Paclitaxel will be administered at a dose of 175 milligrams per meter-squared \[mg/m\^2\] as IV infusion over 3 hours using a rate controlling device every 3 weeks, or at a dose of 80 mg/m\^2 as IV infusion over 1 hour using a rate controlling device every week (only during Cycles 5 to 8).
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 15 milligrams per kilogram \[mg/kg\] as IV infusion over 30-90 min every 3 weeks.

Study Details

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.

Key Dates

First listed
Dec 3, 2012
Start date
Feb 1, 2013
Status verified
Aug 2019
Primary completion
Aug 17, 2016
Completion
Aug 17, 2016

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin + Paclitaxel + Bevacizumab
    Participants will receive 4 cycles of neoadjuvant therapy prior to IDS and 22 cycles of adjuvant therapy before entering long-term follow-up. Each cycle will be 3 weeks in length. Carboplatin and paclitaxel will be administered during Cycles 1 to 8. Bevacizumab will be administered during both the neoadjuvant and the adjuvant treatment periods in Cycles 1 to 26 (no treatment in Cycles 4 and 5).
  • Active Comparator: Carboplatin + Paclitaxel
    Participants will receive 4 cycles of neoadjuvant therapy prior to IDS and 22 cycles of adjuvant therapy before entering long-term follow-up. Each cycle will be 3 weeks in length. Carboplatin and paclitaxel will be administered during Cycles 1 to 8. Bevacizumab will be administered only during the adjuvant treatment period in Cycles 6 to 26.

Primary Outcome Measure

Percentage of Participants with Complete Resection After IDS [ Time Frame: After IDS (approximately 4 months from randomization) ]

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