Urinary Biomarker Study With Sulindac and Difluoromethylornithine

NCT ID: NCT01636128

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-04-30

Brief Summary

The purpose of this study is to determine the effects of 2 drugs (sulindac and Difluoromethylornithine (DFMO)) either alone or in combination on biomarkers found in urine.

Conditions

Focus of Study: Drug Response Biomarkers, Chemoprevention, Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sulindac first (Treatment Sequence B)

Sulindac alone, washout, DFMO alone, then combination of sulindac and DFMO

Group Type: EXPERIMENTAL

difluoromethylornithine

Intervention Type: DRUG

500 mg oral for 14 days, combined with sulindac for 15 days

Sulindac

Intervention Type: DRUG

150 mg oral for 15 days, combined with DFMO for 14 days

DFMO first (Treatment Sequence A)

DFMO alone, followed by washout, sulindac alone, then combination of DFMO and sulindac

Group Type: EXPERIMENTAL

difluoromethylornithine

Intervention Type: DRUG

500 mg oral for 14 days, combined with sulindac for 15 days

Sulindac

Intervention Type: DRUG

150 mg oral for 15 days, combined with DFMO for 14 days

Interventions

difluoromethylornithine

500 mg oral for 14 days, combined with sulindac for 15 days

Intervention Type: DRUG

Sulindac

150 mg oral for 15 days, combined with DFMO for 14 days

Intervention Type: DRUG

Other Intervention Names

DFMO, eflornithine

Eligibility Criteria

Inclusion Criteria

• Age 40-65 years
• Fluent in English
• PS 0 ECOG
• Must be able to discontinue the use of aspirin, aspirin containing products, and other non-steroidal anti-inflammatory agents for the duration of the study agent administration period
• Negative fecal occult blood test
• Hemoglobin > 10g/dl, WBC must be >4,000 mm3, platelets must be > 100,000/mm3
• Serum creatinine must be < 1.5 m/dl
• Serum bilirubin must be < 2.0 mg/dl, AST and ALT must be < 1.5x upper limit of normal range
• Female participants must be postmenopausal (at least 1 year since the last menstrual period), surgically sterilized, or willing to use an effective birth control method (e.g., hormonal contraceptive, oral contraceptives, intrauterine device, diaphragm with spermicide, or abstinence) for the duration of the study. Male subjects must use an effective method of birth control throughout the duration of the study and should not impregnate a female.
• Females of childbearing potential must have a negative serum pregnancy test prior to the start of study medication.
• Able to give signed, written informed consent

Exclusion Criteria

• Requires corticosteroids or nonsteroidal anti-inflammatory agents
• Individuals who are immunosuppressed by virtue of medication or disease. This includes participants known to have AIDS, subjects taking oral steroids, and subjects on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy)
• Current use of phenytoin or sulfonamides
• Current or recent (within 3 months) use of coumadin or other systemic anticoagulants.
• Frequently, chronic or moderate/severe gastric complaints. Upper gastrointestinal problems requiring prescription or nonprescription medical remedies for symptoms of heartburn, dyspepsia, nausea, or abdominal pain > once per week on average
• History of peptic ulcer, occult or gross intestinal bleeding
• Known intercurrent illness, including but no limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal disease, liver disease, ongoing or active infection, psychiatric illness, or other situations that would limit compliance or interfere with the ability to comply with the study regimen.
• History of bleeding or clotting disorders
• Individuals with seizures or history of seizures
• History of abnormal wound healing or repair, or conditions that predisposes to the same including diabetes
• Unwilling or unable to limit alcohol consumption to 2-3 servings per week during the study period (12oz beer, 1 oz per alcoholic beverage, 6 oz per wine)
• Individuals enrolled in or who plan to enroll in a clinical intervention trial. There must be a 30 day period between completing a previous study and enrolling in this study.
• Pregnant or lactating women
• Prior DFMO exposure
• History of allergic reaction (e.g., urticaria, asthma, rhinitis) or gastric intolerance attributed to NSAIDs

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: collaborator

Cancer Prevention Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Patricia Thompson-Carino

Associate Professor, Cellular and Molecular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UA-UB-101

Identifier Type: -

Identifier Source: org_study_id