Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

NCT00026468 | Withdrawn Phase 2

• 5 other identifiers: CDR0000069032R01CA080852P30CA042014UUMC-IRB-5999-96NCI-H01-0079
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis. PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.

Conditions

Colorectal Cancer; Small Intestine Cancer

Keywords

colon cancer; rectal cancer; small intestine cancer

Interventions

exisulind DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * One of the following diagnosis: * Diagnosis of familial adenomatous polyposis * Prior total or subtotal colectomy * Attenuated adenomatous polyposis coli * May have colon intact * 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater PATIENT CHARACTERISTICS: Age: * 18 to 80 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 10 g/dL * Platelet count at least 100,000/mm\^3 * No active hematologic disease Hepatic: * AST and ALT less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 1.5 times ULN * No active hepatic disease Renal: * Creatinine less than 1.5 mg/dL * No active renal disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active peptic ulcer disease * No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival * No prisoners or institutionalized patients * No known allergy to sulindac or related compounds * No active internal malignancy within the past 5 years * No alcohol or drug abuse within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months * No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine) * Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

sulindac sulfone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• James A. DiSario, MD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Primary Completion: July 1, 1999
• Study Completion: July 1, 1999
• Last Updated: July 24, 2013

Record last verified: 2013-07