A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT00483834
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    7.5mg/kg, IV, day 1 of each cycle
  • Irinotecan — DRUG
    200mg/m\^2, IV, day 1 each cycle
  • Capecitabine — DRUG
    1000mg/m\^2 or 750mg/m\^2 for patients over 65yrs old PO BID, day 1-14 each cycle

Study Details

Bevacizumab has recently been shown to improve survival when combined with chemotherapy in patients with previously untreated metastatic colorectal cancer. Bevacizumab is usually given together with infusional 5-FU, which requires a central line. A central line is inconvenient for patients, and may increase risk of infection, and thrombosis. Furthermore, a central line increases resource demands for interventional radiology, chemo daycare. Capecitabine is administered orally, and converted to 5-FU intracellularly. Chronic administration of capecitabine mimics infusional 5-FU. This study is designed to evaluate whether the combination of irinotecan, capecitabine and bevacizumab is effective as a first-line therapy for patients with metastatic colorectal cancer.

Key Dates

Start date
Dec 31, 2006
Status verified
Feb 2019
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: Bevacizumab, Irinotecan and Capecitabine
    Evaluate the efficacy and toxicity of bevacizumab, irinotecan and capecitabine as first-line treatment for patients with metastatic colorectal cancer

Primary Outcome Measure

Objective Response Rate [ Time Frame: Radiological evaluation every 9 weeks, with confirmatory scans 4 weeks after objective response ]

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