A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.

Sponsor
Hoffmann-La Roche
Study ID
NCT01169558
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.
  • Fluoropyrimidine-based Chemotherapy — DRUG
    Fluoropyrimidine-based chemotherapy administered according to standard of care.

Study Details

This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.

Key Dates

First listed
Jul 26, 2010
Start date
May 31, 2006
Status verified
Oct 2016
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
168 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.

Primary Outcome Measure

Safety: Number of Participants With Serious and Specific Adverse Events [ Time Frame: Up to approximately 3 years ]

Related Studies