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A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

NCT00069121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1886

Last updated 2020-03-06

Study results available
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Summary

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. 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)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

Capecitabine

1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle.

DRUG

Oxaliplatin

130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.

DRUG

Leucovorin (LV)

Administered by one of two regimens, as specified in the arm description.

DRUG

5-Fluorouracil (5-FU)

Administered by one of two regimens, as specified in the arm description.

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
2003-04-18
Primary Completion
2011-04-21
Completion
2011-04-21

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Mexico
  • New Zealand
  • Panama
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • 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 NCT00069121 on ClinicalTrials.gov