Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Giving healthy volunteers sulindac capsules or sulindac tablets may help doctors learn which form of the drug may be more effective in preventing cancer. PURPOSE: This randomized clinical trial is studying sulindac capsules to see how well they work compared with sulindac tablets in healthy volunteers.
Detailed description
OBJECTIVES: Primary * Compare the systemic exposure of sulindac tablets vs sulindac capsules in healthy volunteers. Secondary * Compare the terminal half-life and time of peak drug concentration of sulindac tablets vs sulindac capsules. OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 treatment arms. * Arm I: Participants receive one sulindac capsule followed 7-10 days later by one sulindac tablet. * Arm II: Participants receive one sulindac tablet followed 7-10 days later by one sulindac capsule. Blood is collected periodically during treatment for pharmacokinetic studies. After completion of study therapy, participants are followed at 7-10 days. PROJECTED ACCRUAL: A total of 28 participants will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Healthy volunteer PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Hemoglobin ≥ 12.0 g/dL (women) * Hemoglobin ≥ 13.5 g/dL (men) * WBC \> 3,000/mm³ * Platelet count \> 100,000/mm³ * Absolute neutrophil count \> 1,500/mm³ * Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * ALT ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30 mL/min * No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria * No condition that interferes with ingestion or absorption of oral medications * No cancer within the past 3 years except nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was previously treated \> 6 months ago * No uncontrolled concurrent illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Myocardial infarction in the past 6 months * Chronic renal disease * Chronic liver disease * Hypertension that is difficult to control * Psychiatric illness or social situations that would limit study compliance * No other significant clinical disorder or laboratory finding that would preclude study participation * No consumption of alcoholic or caffeinated beverages for ≥ 24 hours prior to study drug administration and until all blood samples have been drawn * Willing to provide required biologic specimens PRIOR CONCURRENT THERAPY: * More than 6 months since prior investigational agents * More than 6 months since prior regular use of (defined as a frequency of 7 consecutive days for \> 3 weeks or \> 21 days total) or other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors including, but not limited to, the following: * Ibuprofen * Ketoprofen * Naproxen * More than 6 weeks since prior oral corticosteroids * More than 30 days since prior and no concurrent use of any of the following: * Methotrexate * Corticosteroids * Warfarin * Ticlopidine * Clopidogrel * Low molecular weight heparins * Abciximab * Dipyridamole * Eptifibatide * Tirofiban * Lithium * Cyclosporine * Hydralazine * Angiotensin-converting enzymes (ACE) inhibitors * ACE-receptor antagonists allowed * Angiotensin-receptor blockers * Ginkgo * Ketorolac * Levofloxacin * Loop diuretics * Meadowsweet * Selective serotonin reuptake inhibitors * Danaparoid * No concurrent regular aspirin use unless prescribed by a physician for prevention * A maximum of one aspirin (81 mg/day) allowed * No concurrent herbal products (e.g., saw palmetto or Hypericum perforatum \[St. John's wort\])
Countries
United States