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

NCT ID: NCT00305643

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Arm I: Celecoxib + Capecitabine

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

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle.

Celecoxib

Intervention Type: DRUG

200 mg given orally twice a day for each 21 day cycle.

Radiation Therapy

Intervention Type: PROCEDURE

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.

Arm II: Placebo + Capecitabine

Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day)

Group Type: PLACEBO_COMPARATOR

Capecitabine

Intervention Type: DRUG

Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle.

Radiation Therapy

Intervention Type: PROCEDURE

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.

Placebo

Intervention Type: DRUG

Oral placebo twice daily on days 1-21

Interventions

Capecitabine

Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle.

Intervention Type: DRUG

Celecoxib

200 mg given orally twice a day for each 21 day cycle.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Placebo

Oral placebo twice daily on days 1-21

Intervention Type: DRUG

Other Intervention Names

Xeloda; Celebrex; RT; XRT

Eligibility 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. Eastern Cooperative Oncology Group (ECOG) Performance Status </= 2

6. Adequate organ function: a. Total bilirubin </= 1.5 * the institutional upper-normal limits (IUNL) b. aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) </= 2.5 * IUNL c. Patients with liver mets AST/(SGOT) and/or ALT(SGPT) < 5 * IUNL d. Alkaline phosphatase </= 5 * 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 (Nonsteroidal anti-inflammatory drugs)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 transient ischemic attack (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 gastrointestinal (GI) bleed within 12 months of enrollment.

9. Use of warfarin.

10. Patients with uncontrolled brain metastasis.

11. Patients may have had prior Hand-foot syndrome (HFS) but it must be completely resolved for >/= 4 weeks.

12. No concurrent radiation therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Kopetz, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

CCOP - Kansas City

Kansas City, Missouri, United States

Cancer Research for the Ozarks

Springfield, Missouri, United States

Hematology Oncology Associates of Central New York, PC - Northeast Center

East Syracuse, New York, United States

CCOP - Columbus

Columbus, Ohio, United States

CCOP - Main Line Health

Wynnewood, Pennsylvania, United States

CCOP - Greenville

Greenville, South Carolina, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Scott and White Cancer Institute

Temple, Texas, United States

CCOP - Northwest

Tacoma, Washington, United States

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

MBCCOP - San Juan

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Related Links

http://cancer.gov/clinicaltrials

Clinical trial summary, the National Cancer Institute's PDQ® database

http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

MDA-CCC-0326

Identifier Type: OTHER

Identifier Source: secondary_id

MDA-2005-0328

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000458042

Identifier Type: REGISTRY

Identifier Source: secondary_id

2005-0328

Identifier Type: -

Identifier Source: org_study_id