Status:
COMPLETED
Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
40+ years
Phase:
NA
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 ...
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 o...
Eligibility Criteria
Inclusion
- 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 \[St. John's wort\])
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00343629
Start Date
April 1 2006
End Date
October 1 2007
Last Update
April 28 2015
Active Locations (1)
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1
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905