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A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT00642603 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-03-29

Study results available
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Summary

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Conditions

Interventions

DRUG

capecitabine [Xeloda]

1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

DRUG

capecitabine [Xeloda]

1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

DRUG

bevacizumab [Avastin]

5 mg/kg taken intravenously on Day 1 of each 2 week cycle

DRUG

oxaliplatin

85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

DRUG

irinotecan

135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

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 NCT00642603 on ClinicalTrials.gov