Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sulindac

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])