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(Withdrawn due to low accrual.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:
M.D. Anderson Cancer Center
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
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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:
|
|
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:
|
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:
- 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.
- 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.
- Men and women from all ethnic and racial groups.
- >/= 18 years old
- ECOG Performance Status </= 2
- 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
- Adequate bone marrow function: (a) Leukocytes >/= 3,000/microL; (b) Absolute neutrophil count >/= 1,500/microL; (c) Platelets >/= 100,000/microL
- 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.
- Negative pregnancy test for women of childbearing age.
- Must have the ability to understand and the willingness to provide a written informed consent to participate in the study.
- Controlled brain metastasis (i.e. stereotactic surgery, surgery steroids, anticonvulsants).
Exclusion Criteria:
- History of allergies to sulfonamide, aspirin, any NSAID or 5FU or any COX-2 inhibitor.
- Any regular use of COX-2 inhibitors, NSAIDS or aspirin >325 mg more than twice a week.
- Pregnancy or lactation.
- History of significant neurological or psychiatric disorders that would impede giving consent, treatment or follow-up.
- 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
- Serious uncontrolled active infection.
- Patients who cannot comply with taking and documenting oral study medications.
- History of active peptic ulcer disease or upper GI bleed within 12 months of enrollment.
- Use of warfarin.
- Patients with uncontrolled brain metastasis.
- Patients may have had prior HFS but it must be completely resolved for >/= 4 weeks.
- No concurrent radiation therapy.
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 | |
| 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 May 19, 2013