Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Conditions

• Recurrent Platinum-sensitive Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
• PLD — DRUG
• Bevacizumab — BIOLOGICAL

Study Details

Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.

Key Dates

First listed

Apr 23, 2013

Start date

May 31, 2013

Status verified

Jul 2021

Primary completion

Jan 31, 2021

Completion

Jan 31, 2021

Study Design

Enrollment

682 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control Arm
  Patients receive bevacizumab 15 mg/kg iv on day 1 followed by gemcitabine 1000mg/m² iv on day 1 \& 8 and carboplatin AUC4 iv on day 1 every 3 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
• Experimental: Research Arm
  Patients receive bevacizumab 10 mg/kg iv on day 1 \& 15 followed by PLD 30mg/m² iv on day 1 carboplatin AUC4 iv on day 1 every 4 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.

Primary Outcome Measure

investigator-determined progression-free survival [ Time Frame: every 12 weeks until progression or up to 30 months (whichever occurs first) ]