Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
Condition: Breast Cancer; Colorectal Cancer; Pain
MeSH terms: Breast Neoplasms; Colorectal Neoplasms
Intervention: Capecitabine; Celecoxib; Radiation Therapy; Placebo
Intervention description: Initial dose of 750-1500 mg/m^2 orally twice a day for each 21 day cycle.; 200 mg given orally twice a day for each 21 day cycle.; 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.; Oral placebo twice daily on days 1-21
Intervention MeSH terms: Celecoxib; Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

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.