S0820, Adenoma and Second Primary Prevention Trial | NCT01349881

ID	Type	Description	Link
U10CA037429	U.S. NIH Grant/Contract		View source
NCI-2012-02067	Other Identifier	NCI

Status Module

Name	Class
National Cancer Institute (NCI)	NIH
Cancer Prevention Pharmaceuticals, Inc.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
eflornithine placebo & sulindac placebo	Placebo Comparator	Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.	Drug: Eflornithine placebo & sulindac placebo
Eflornithine & sulindac placebo	Experimental	Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo one tablet PO daily for 3 years.	Drug: eflornithine & sulindac placebo
Eflornithine placebo & sulindac	Experimental	Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.	Drug: Eflornithine placebo & sulindac
Eflornithine plus sulindac	Experimental	Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.	Drug: Eflornithine plus sulindac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eflornithine placebo & sulindac placebo	Drug	Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years	eflornithine placebo & sulindac placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC)	High risk adenoma is defined as either advanced adenoma (villous or tubulovillous histology, size >= 1 cm, or high grade dysplasia) or multiple adenomas (3 or more each > 0.3 cm). The primary analysis of the 3-year event rate will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A two-arm binomial design without continuity correction will be used.	3 years after registration

Secondary Outcomes

Measure	Description	Time Frame
Total advanced colorectal event rate, defined as the number of patients with at least one high risk adenoma, second primary CRC, CRC recurrence, or metastasis	The analysis will be performed using logistic regression, testing the main effect of treatment and adjusting for the baseline stratification factor. A time-to-event analysis will be conducted if there is no evidence of differential rates of on-study colonoscopies. To evaluate whether intervention effects are enduring, an analysis of post-treatment follow-up, examining colorectal event rates through year 8 will be performed.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190 mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
At least 30 days from completion of adjuvant chemo and RT.
Presence of gastroesophageal reflux disease acceptable if controlled with medications
Not receiving or planning to receive concomitant intravenous corticosteroids on a regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular predictable intermittent basis. NSAID use must not exceed 10 days per month; Maximum aspirin dose
- 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.
Able to swallow oral medications
Laboratory: WBC ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL. (A total WBC ≥ 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC ≥ 3.4 x 1000/mcL for non-Hispanic black females. Serum bilirubin ≤ 2.0 mg/dL and AST (SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN
Zubrod PS 0-1, 18 years of age or older
Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only
Offered opportunity to participate in blood specimen banking

Exclusion Criteria:

History of colon resection > 40 cm
Mid-low rectal cancer
Recurrent or metastatic disease
High cardiovascular risk; Uncontrolled hypertension
Planned radiation therapy or additional chemotherapy
Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram
Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs
Significant medical or psychiatric condition that would preclude study completion (8 years)
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham Cancer Center		Birmingham	Alabama	35233	United States
Anchorage Associates in Radiation Medicine

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D009952	Ornithine
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds