Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Rare Diseases

Adenomatous Polyposis Coli

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Amino Acids

Eflornithine

Sulindac

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Ornithine

Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]

Eflornithine placebo \[three tablets orally once a day\]

Eflornithine Placebo

Sulindac \[one tablet orally once a day\]

Sulindac 150 MG

Sulindac placebo \[one tablet orally once a day\]

Sulindac placebo

Carol Burke, M.D.

James Church, M.D.

Gabriella Möslein, M.D.

The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

Phase III Trial of the Safety and Efficacy of Eflornithine Combined With Sulindac Compared to Eflornithine, Sulindac as Single Agents in Patients With Familial Adenomatous Polyposis

Progression of disease by evaluation of FAP-related events over the course of study treatment

Global assessment of change in upper GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.

Global assessment of change in lower GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.

Cancer Prevention Pharmaceuticals, Inc.

Eflornithine 750 mg and Sulindac 150 mg

Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]

Sulindac 150 MG: Sulindac \[one tablet orally once a day\]

Eflornithine Plus Sulindac

Eflornithine 750 mg and Placebo

Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]

Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]

Eflornithine Plus Sulindac Placebo

Sulindac 150 mg and Placebo

Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]

Sulindac 150 MG: Sulindac \[one tablet orally once a day\]

Sulindac Plus Eflornithine Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

Netherlands

Belgium

United States

United Kingdom

Germany

Spain

Region of Enrollment

Michelle Boytim

Intent to treat population with all FAP-related events

Number with FAP-related events

Number with Lower GI FAP-related events

Intent to treat population with 171 subjects. Intent to treat population with lower GI anatomy (ower GI population) to evaluate lower GI FAP related events with 158 subjects.

Number of Subjects With Any FAP-related Event.

Improved

Not Improved

Improvement in Investigator Upper GI Assessment

Improvement in Investigator Lower GI Assessment

Overall Study

Antipyretics

Fibrinolytic Agents

Platelet Aggregation Inhibitors

Gastrointestinal Agents

Herbal and Botanical

Aspirin

Ursodeoxycholic Acid

Cola

Patients receive oral aspirin once daily for 12 months.

Acetylsalicylic acid (Aspirin)

Patients receive oral sulindac twice daily for 12 months.

Patients receive oral ursodiol three times daily for 12 months.

Ursodiol

Sulindac Placebo

Robert S. Bresalier, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer.

PURPOSE: This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer.

OBJECTIVES:

* Determine the percentage change in colorectal aberrant crypt foci (ACF) in patients with a history of colorectal cancer or at high risk for colorectal cancer when treated with sulindac vs aspirin vs ursodiol.
* Determine the safety and efficacy of these drugs, in terms of ability to cause regression of existing colorectal ACF and prevent new ACF development, in these patients.

OUTLINE: This is a partially blinded, randomized, placebo-controlled study. Patients are stratified according to colorectal neoplasia (adenoma vs carcinoma). Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive oral sulindac twice daily.
* Arm II: Patients receive oral aspirin once daily.
* Arm III: Patients receive oral ursodiol three times daily.
* Arm IV: Patients receive oral sulindac placebo twice daily. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.

Patients undergo a colonoscopy at baseline and at the end of treatment.

Patients are followed at 2 months after the end of treatment.

PROJECTED ACCRUAL: A total of 172 patients (43 per treatment arm) with a history of colorectal cancer or adenomas will be accrued for this study. A total of 20 additional patients with no elevated risk of colorectal neoplasia will be accrued, but not randomized, for this study.

Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer

Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)	NCT01483144	Familial Adenom...	Eflornithine Eflornithine Pl... Sulindac 150 MG Sulindac placeb...	18 Years -	Cancer Prevention Pharmaceuticals, Inc.
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)	NCT01483144	Familial Adenom...	Eflornithine Eflornithine Pl... Sulindac 150 MG Sulindac placeb...	18 Years -	Cancer Prevention Pharmaceuticals, Inc.
Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer	NCT00062023	Colorectal Canc...	Acetylsalicylic... Sulindac Ursodiol Sulindac Placeb...	40 Years - 80 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for sulindac placebo