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

This study has been terminated.
(Withdrawn due to low accrual. No data analyzed.)
Sponsor:
Collaborators:
Pfizer
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00305643
First received: March 21, 2006
Last updated: August 11, 2009
Last verified: August 2009
  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
Colorectal Cancer
Pain
Drug: Capecitabine
Drug: Celecoxib
Procedure: Radiation Therapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence of hand/foot syndrome (HFS) > grade 1 as assessed by NCI CTC v3.0 criteria at 16 weeks [ Time Frame: Interim analysis at 16 Weeks, with evaluations and blood test every 3 weeks. ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Celecoxib along with standard capecitabine treatment.
Drug: Capecitabine
Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.
Other Name: Xeloda
Drug: Celecoxib
200 mg given orally twice a day for each 21 day cycle.
Other Name: Celebrex
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.
Other Names:
  • RT
  • XRT
Placebo Comparator: Arm II
Placebo with standard capecitabine treatment.
Drug: Capecitabine
Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.
Other Name: Xeloda
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.
Other Names:
  • RT
  • XRT

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

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 </= 2
  6. Adequate organ function: a. Total bilirubin </= 1.5 x the institutional upper-normal limits (IUNL) b. AST (SGOT) and/or ALT (SGPT) </= 2.5 x IUNL c. Patients with liver mets AST/(SGOT) and/or ALT(SGPT) < 5 x IUNL d. Alkaline phosphatase </= 5 x IUNL e. Creatinine Clearance > 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
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
Pfizer
Investigators
Principal Investigator: Scott Kopetz, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Scott Kopetz, MD / Assistant Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00305643     History of Changes
Other Study ID Numbers: 2005-0328, MDA-CCC-0326, MDA-2005-0328, CDR0000458042
Study First Received: March 21, 2006
Last Updated: August 11, 2009
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Celecoxib
Capecitabine
Fluorouracil
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014