MedTrace Logo

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

NCT00483834 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Bevacizumab

7.5mg/kg, IV, day 1 of each cycle

DRUG

Irinotecan

200mg/m\^2, IV, day 1 each cycle

DRUG

Capecitabine

1000mg/m\^2 or 750mg/m\^2 for patients over 65yrs old PO BID, day 1-14 each cycle

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Eric Chen · Princess Margaret Hospital, University Health Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483834 on ClinicalTrials.gov