Bevacizumab in Treating Patients Who Have Undergone First-Line Therapy for Metastatic Colorectal Cancer

Sponsor
Swiss Cancer Institute
Study ID
NCT00544700
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity
  • no maintenance — OTHER
    No treatment until progression

Study Details

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab as maintenance therapy is more effective than observation in treating patients with colorectal cancer. PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in treating patients who have undergone first-line therapy for metastatic colorectal cancer.

Key Dates

First listed
Oct 16, 2007
Start date
Nov 26, 2007
Status verified
Feb 2020
Primary completion
Jan 21, 2013
Completion
Dec 12, 2019

Study Design

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

Arms

  • Active Comparator: Arm A: Bevacizumab monotherapy
    Bevacizumab maintenance monotherapy
  • Other: Arm B: No maintenance
    No antitumor treatment until progression

Primary Outcome Measure

Time to progression (TTP) [ Time Frame: From randomization until documented progressive disease or death due to tumor. ]

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