A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00484939
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
  • Capecitabine — DRUG
    Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.

Study Details

This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) alone. No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.

Key Dates

First listed
Jun 12, 2007
Start date
Jul 31, 2007
Status verified
Jan 2015
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

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

Arms

  • Experimental: Bevacizumab + capecitabine
    Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
  • Active Comparator: Capecitabine
    Participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

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