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A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

NCT00069108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2016-04-01

Study results available
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Summary

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

5 FU

As prescribed, in 2 week cycles

DRUG

Leucovorin

As prescribed, in 2 week cycles

DRUG

Oxaliplatin

As prescribed, in 3 week cycles

DRUG

Oxaliplatin

As prescribed, in 2 week cycles

DRUG

capecitabine [Xeloda]

1000mg/m2 po bid on days 1-15 of each 3 week cycle

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
2003-07-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States
  • Belgium
  • Canada
  • Croatia
  • Finland
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Poland
  • Puerto Rico
  • Serbia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

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 NCT00069108 on ClinicalTrials.gov