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Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

NCT00305643 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-12-24

Study results available
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Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen hand-foot syndrome caused by capecitabine.

PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal cancer.

Conditions

Interventions

DRUG

Capecitabine

Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle.

DRUG

Celecoxib

200 mg given orally twice a day for each 21 day cycle.

PROCEDURE

Radiation Therapy

Some patients may undergo radiation therapy 5 days a week for 5-6 weeks, and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine once daily on days 1-14.

DRUG

Placebo

Oral placebo twice daily on days 1-21

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Pfizer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Scott Kopetz, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Puerto Rico

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 NCT00305643 on ClinicalTrials.gov