Conditions: Breast Cancer Colorectal Cancer Pain
Keywords: Hand-Foot Syndrome cancer-related problem/condition drug/agent toxicity by tissue/organ pain palmar-plantar erythrodysesthesia stage IV breast cancer male breast cancer recurrent breast cancer stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer Celecoxib Celebrex Capecitabine Xeloda
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11
Healthy volunteers: no

Brief 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.

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.

Arms:
arm 1: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day). arm 2: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day)

Interventions: intervention 1: Capecitabine intervention 2: Celecoxib intervention 3: Radiation Therapy intervention 4: Placebo
Intervention descriptions: intervention 1: Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle. intervention 2: 200 mg given orally twice a day for each 21 day cycle. intervention 3: 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. intervention 4: Oral placebo twice daily on days 1-21

Protocol document: