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

PHASE3TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Breast CancerColorectal CancerPain
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

Trial Locations (14)

19096

CCOP - Main Line Health, Wynnewood

29615

CCOP - Greenville, Greenville

43215

CCOP - Columbus, Columbus

49503

CCOP - Grand Rapids, Grand Rapids

54449

Marshfield Clinic - Marshfield Center, Marshfield

64131

CCOP - Kansas City, Kansas City

65804

Cancer Research for the Ozarks, Springfield

76508

Scott and White Cancer Institute, Temple

95403

CCOP - Santa Rosa Memorial Hospital, Santa Rosa

49007-3731

CCOP - Kalamazoo, Kalamazoo

13057-4510

Hematology Oncology Associates of Central New York, PC - Northeast Center, East Syracuse

77030-4009

M. D. Anderson Cancer Center at University of Texas, Houston

98405-0986

CCOP - Northwest, Tacoma

00936

MBCCOP - San Juan, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Pfizer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT00305643 - Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer | Biotech Hunter | Biotech Hunter