Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Active 18 and over NCI MDA-CCC-0326 MDA-2005-0328, NCT00305643

Objectives

1. 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.

Entry 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

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

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/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 342 patients will be accrued for this study.

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

University of Texas M.D. Anderson CCOP Research Base

E. Scott Kopetz, MD, Principal investigator		Ph: 713-792-2828; 800-392-1611

U.S.A.
California
	Santa Rosa
	CCOP - Santa Rosa Memorial Hospital
		Ian Anderson, MD	Ph:  707-521-3830
Michigan
	Grand Rapids
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-391-1230
			Email: marianne.lange@grcop.org
	Kalamazoo
	CCOP - Kalamazoo
		Raymond Lord, MD	Ph:  269-373-7458
			Email: rlord@wmcc.org
Missouri
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
			Email: rgaur@saint-lukes.org
	Springfield
	Cancer Research for the Ozarks
		John Goodwin, MD	Ph:  417-889-8099
			Email: jgoodwin@sprg.mercy.net
New York
	East Syracuse
	Hematology Oncology Associates of Central New York, PC - Northeast Center
		Jeffrey Kirshner, MD	Ph:  315-472-7504
			Email: jkirshner@hoacny.com
Ohio
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-488-2118
			Email: kueblep@ohiohealth.com
Pennsylvania
	Wynnewood
	CCOP - Main Line Health
		Paul Gilman, MD	Ph:  610-645-2057
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-241-6251
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	Temple
	Scott and White Cancer Institute
		Lucas Wong, MD	Ph:  254-724-7048
			Email: lwong@swmail.sw.org
Washington
	Tacoma
	CCOP - Northwest
		Lauren Colman, MD	Ph:  253-552-1677
			Email: lauren.colman@multicare.org
Wisconsin
	Marshfield
	Marshfield Clinic - Marshfield Center
		Tarit Banerjee, MD, FACP	Ph:  715-387-5134
Puerto Rico
	San Juan
	MBCCOP - San Juan
		Luis Baez-Diaz, MD, FACP	Ph:  787-641-3693
			Email: sjccop@prtc.net

Registry Information
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
Trial Start Date		2006-01-25
Registered in ClinicalTrials.gov		NCT00305643
Date Submitted to PDQ		2005-11-30
Information Last Verified		2007-10-11
NCI Grant/Contract Number		CA16672