Irinotecan, Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT00875771
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Capecitabine+Irinotecan+Bevacizumab — DRUG
    * Capecitabine: 1000 mg/m2, bid, oral, days 2-8. Every 2 weeks * Irinotecan: 175 mg/m2, iv infusion 90 minutes, day 1, every 2 weeks * Bevacizumab: 5 mg/kg day 1, every 2 Weeks Treatment will be given until disease progression or unacceptable toxicity.

Study Details

The purpose of this study is to determine efficacy and safety of the biweekly scheme with Capecitabine and Irinotecan, plus bevacizumab in patients with metastatic colorectal cancer.

Key Dates

Start date
Apr 30, 2009
Status verified
Jul 2017
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

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

Arms

  • Experimental: 1
    * Capecitabine: 1000 mg/m2, bid, oral, days 2-8. Every 2 weeks * Irinotecan: 175 mg/m2, iv infusion 90 minutes, day 1, every 2 weeks * Bevacizumab: 5 mg/kg day 1, every 2 Weeks

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 2009-2012 ]

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