Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine in Patients With Metastatic Breast or Colorectal Cancer - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00305643

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Cancer-Related Problem/Condition Colorectal Cancer Pain	Drug: capecitabine Drug: celecoxib Procedure: radiation therapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Foot Health

Drug Information available for: Capecitabine Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Stage distribution of HFS
Incidence of HFS > grade 1 as assessed by WHO criteria at 16 weeks
Overall symptom burden

Estimated Enrollment:	342
Study Start Date:	January 2006
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral celecoxib twice daily on days 1-21 in the absence of disease progression or unacceptable toxicity. Some patients may receive oral capecitabine once daily on days 1-14 every 21 days or 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 once daily on days 1-14.	Drug: capecitabine Given orally Drug: celecoxib Given orally Procedure: radiation therapy Some patients may undergo radiation therapy 5 days a week for 5-6 weeks.
Arm II: Placebo Comparator Patients receive oral placebo twice daily on days 1-21 in the absence of disease progression or unacceptable toxicity. Some patients may receive oral capecitabine once daily on days 1-14 every 21 days or 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 once daily on days 1-14.	Drug: capecitabine Given orally Procedure: radiation therapy Some patients may undergo radiation therapy 5 days a week for 5-6 weeks.

Arms

Assigned Interventions

Arm I: Experimental

Patients receive oral celecoxib twice daily on days 1-21 in the absence of disease progression or unacceptable toxicity. Some patients may receive oral capecitabine once daily on days 1-14 every 21 days or 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 once daily on days 1-14.

Drug: capecitabine

Given orally

Drug: celecoxib

Given orally

Procedure: radiation therapy

Some patients may undergo radiation therapy 5 days a week for 5-6 weeks.

Arm II: Placebo Comparator

Patients receive oral placebo twice daily on days 1-21 in the absence of disease progression or unacceptable toxicity. Some patients may receive oral capecitabine once daily on days 1-14 every 21 days or 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 once daily on days 1-14.

Drug: capecitabine

Given orally

Procedure: radiation therapy

Some patients may undergo radiation therapy 5 days a week for 5-6 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of metastatic colorectal cancer or breast cancer
Scheduled to receive capecitabine alone or in combination with radiotherapy
Any number or type of prior treatment regimens for metastatic disease allowed
No uncontrolled brain metastases
- Controlled brain metastasis (i.e., stereotactic surgery, anticonvulsants) allowed
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Male or female
Menopausal status not specified
ECOG performance status 0-2
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and/or ALT ≤ 5 times ULN
Alkaline phosphatase ≤ 5 times ULN
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine clearance > 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of allergies to sulfonamide, aspirin, NSAIDs, fluorouracil, or any COX-2 inhibitor
No history of significant neurologic or psychiatric disorders that would preclude study treatment
No serious illness or medical condition, including the following:
- Uncontrolled congestive heart failure
- Uncontrolled hypertension or arrhythmia
- Active angina pectoris
- Any history of myocardial infarction, stroke, or transient ischemic attack
No serious, uncontrolled active infection
No history of active peptic ulcer disease or upper gastrointestinal bleeding within the past 12 months
Prior hand/foot syndrome must have been completely resolved for ≥ 4 weeks

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No more than 3 prior treatment regimens for metastatic colorectal cancer
No concurrent use of warfarin
No concurrent cyclooxygenase (COX)-inhibitors, nonsteroidal anti-inflammatory drugs (NSAID), or aspirin at a dose of > 325 mg > twice weekly
No concurrent radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305643

Locations

United States, California
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, New York
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, United States, 13057-4510
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
United States, Pennsylvania
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Scott and White Cancer Institute
Temple, Texas, United States, 76508
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Puerto Rico
MBCCOP - San Juan
San Juan, Puerto Rico, 00936

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

E. Scott Kopetz, MD

M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000458042, MDA-CCC-0326, MDA-2005-0328
Study First Received:	March 21, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00305643
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Capecitabine
Celecoxib
Digestive System Neoplasms
Skin Diseases
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Breast Neoplasms
Pain
Intestinal Diseases

Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Breast Neoplasms, Male
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009