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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Colorectal Cancer; Pain

Intervention: Capecitabine (Drug); Celecoxib (Drug); Radiation Therapy (Procedure)

Phase: Phase 3

Status: Terminated

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Scott Kopetz, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center


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.

Clinical Details

Official title: A Multicenter Phase III Placebo-Controlled Trial of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar (Hand/Foot) Syndrome in Patients With Metastatic Breast and Colorectal Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome: Incidence of hand/foot syndrome (HFS) > grade 1 as assessed by NCI CTC v3.0 criteria at 16 weeks

Detailed description: OBJECTIVES:

- Determine the efficacy of celecoxib in reducing the incidence and severity of hand/foot

syndrome caused by capecitabine in patients with metastatic breast cancer or colorectal cancer. OUTLINE: This is a placebo-controlled, randomized, double-blind, multicenter study. Patients are stratified according to metastatic disease (breast vs colorectal), ECOG performance status (0 or 1 vs 2), prior chemotherapy (yes vs no). Patients receive 1 of 2 treatment regimens.

- Regimen A (concurrent radiotherapy): Patients undergo radiotherapy 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 as in regimen B.

- Regimen B (no radiotherapy): Patients receive oral capecitabine once daily on days

1-14. Courses repeat every 21 days. Patients are also randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral celecoxib twice daily on days 1-21.

- Arm II: Patients receive oral placebo twice daily on days 1-21. In both arms, treatment

repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Patients with metastatic colorectal cancer or breast cancer who are scheduled*** to receive capecitabine with an initial dose in the range of 750-1500 mg/m2** twice daily (total daily dose in the range of 1500-3000 mg/m2) alone or in combination with one or more other agents. ***Patients may enter the study after having received capecitabine for up to 21 days prior to study entry. **Doses may be rounded upward or downward per physician discretion to utilize 500mg tablets. 2. Patients with either metastatic colorectal or metastatic breast cancer may have received any number or type of prior treatment regimens for metastatic disease or they may have received no prior treatment for metastatic disease. 3. Men and women from all ethnic and racial groups. 4. >/= 18 years old 5. ECOG Performance Status 50 ml/min 7. Adequate bone marrow function: (a) Leukocytes >/= 3,000/microL; (b) Absolute neutrophil count >/= 1,500/microL; (c) Platelets >/= 100,000/microL 8. Women of childbearing age and all men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. 9. Negative pregnancy test for women of childbearing age. 10. Must have the ability to understand and the willingness to provide a written informed consent to participate in the study. 11. Controlled brain metastasis (i. e. stereotactic surgery, surgery steroids, anticonvulsants). Exclusion Criteria: 1. History of allergies to sulfonamide, aspirin, any NSAID or 5FU or any COX-2 inhibitor. 2. Any regular use of COX-2 inhibitors, NSAIDS or aspirin >325 mg more than twice a week. 3. Pregnancy or lactation. 4. History of significant neurological or psychiatric disorders that would impede giving consent, treatment or follow-up. 5. Any serious illness or medical condition: uncontrolled congestive heart failure, uncontrolled hypertension or arrhythmia, active angina pectoris, any history of myocardial infarction, stroke or TIA 6. Serious uncontrolled active infection. 7. Patients who cannot comply with taking and documenting oral study medications. 8. History of active peptic ulcer disease or upper GI bleed within 12 months of enrollment. 9. Use of warfarin. 10. Patients with uncontrolled brain metastasis. 11. Patients may have had prior HFS but it must be completely resolved for >/= 4 weeks. 12. No concurrent radiation therapy.

Locations and Contacts

MBCCOP - San Juan, San Juan 00936, Puerto Rico

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Cancer Research for the Ozarks, Springfield, Missouri 65804, United States

Hematology Oncology Associates of Central New York, PC - Northeast Center, East Syracuse, New York 13057-4510, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

CCOP - Main Line Health, Wynnewood, Pennsylvania 19096, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

M. D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

Scott and White Cancer Institute, Temple, Texas 76508, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Additional Information

UT MD Anderson Cancer Center website

Starting date: January 2006
Last updated: August 11, 2009

Page last updated: August 23, 2015

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