Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer

Sponsor
AGO Study Group
Study ID
NCT01462890
Phase
PHASE3
Status
Completed

Conditions

  • Fallopian Tube Neoplasms
  • Genital Diseases, Female
  • Ovarian Diseases
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44
  • Paclitaxel — DRUG
    175 mg/m², iv on day 1 every 3 weeks for 6 cycles
  • Carboplatin — DRUG
    AUC 5, iv on day 1 every 3 weeks for 6 cycles
  • specialized pathology review (Germany only) — OTHER
    before randomization

Study Details

The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.

Key Dates

First listed
Nov 1, 2011
Start date
Nov 30, 2011
Status verified
Jul 2022
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

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

Arms

  • Other: Control Arm
    Patients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab iv alone every 3 weeks for 16 cycles.
  • Experimental: Research Arm
    Patients receive bevacizumab iv followed by paclitaxel iv and carboplatin iv on day 1. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab iv alone every 3 weeks for 38 cycles.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months ]

Related Studies