Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
NCT00305643
ABOUT THIS STUDY
FOR MORE INFORMATION
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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).
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.
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Descriptive Information | ||||
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Brief Title ICMJE | Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer | |||
Official Title ICMJE | 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 | |||
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:
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.
Patients are also randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Supportive Care | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 11 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | October 2008 | |||
Actual Primary Completion Date | October 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00305643 | |||
Other Study ID Numbers ICMJE | 2005-0328 MDA-CCC-0326 ( Other Identifier: NCI ) MDA-2005-0328 ( Other Identifier: NCI ) CDR0000458042 ( Registry Identifier: NCI ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | M.D. Anderson Cancer Center | |||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | November 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |