A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00700102
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Chemotherapy — DRUG
    As prescribed
  • Bevacizumab — DRUG
    Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.

Study Details

This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

Key Dates

First listed
Jun 18, 2008
Start date
Feb 28, 2006
Status verified
Jul 2015
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

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

Arms

  • Active Comparator: Chemotherapy
    Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
  • Experimental: Chemotherapy + Bevacizumab
    Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal

Primary Outcome Measure

Overall Survival: Time From Randomization to Death From Any Cause [ Time Frame: within 6.5 years ]

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