Phase 3 N=375 Randomized Double-blind Prevention

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

Precancerous Condition

Bottom Line

View on ClinicalTrials.gov: NCT00118365 ↗

Enrolled (actual)

375

Serious AEs

18.4%

Results posted

Jan 2015

Primary outcome: Primary: Detection of Any Adenoma at the End of the Study — 17; 53; 121; 76 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: placebo (Other); eflornithine (Drug); sulindac (Drug); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Detection of Any Adenoma at the End of the Study	17; 53; 121; 76	—
SECONDARY Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment	12; 3; 19; 21; 41; 41	—
SECONDARY Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment	7; 10; 24; 31; 63; 56	—
SECONDARY Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment	5; 12; 31; 24; 59; 60	—
SECONDARY Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment	1; 8; 4; 15; 10; 27	—
SECONDARY Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment	9; 7; 22; 28; 52; 53	—
SECONDARY Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment	8; 8; 17; 33; 75; 30	—
SECONDARY Adverse Events With a Grade of 3 and Above	46; 37	—
SECONDARY Baseline Putrescine by ODC Genotype	0.47; 0.56	—
SECONDARY Baseline Spermidine by ODC Genotype	1.99; 2.17	—
SECONDARY Baseline Spermine by ODC Genotype	6.82; 7.29	—
SECONDARY At the End of the Study - Putrescine Response by ODC Genotype	26; 21; 12; 12; 32; 19	—
SECONDARY At the End of the Study - Spermidine Response by ODC Genotype	25; 12; 15; 11; 32; 28	—
SECONDARY At the End of the Study - Spermine Response by ODC Genotype	7; 7; 18; 10; 51; 33	—
SECONDARY Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group	7; 9; 22; 18	—
SECONDARY Biomarker in Adenoma: Apoptosis	2; 4; 7; 20; 1; 23	—
SECONDARY Biomarker in Adenoma - Ki-67	59.5; 63.9	—
SECONDARY Biomarker in Adenoma: CEA	1; 5; 5; 15; 6; 35	—
SECONDARY Biomarker in Adenoma: Sialyl-TN (B72.3)	3; 11; 7; 32; 2; 17	—
SECONDARY Biomarker in Adenoma - p53	75.6; 70.3	—
SECONDARY Biomarker in Adenoma: Bcl-2	4; 17; 4; 25; 3; 14	—

Summary

This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer

Eligibility Criteria

Criteria:

History of >= 1 surgically resected adenomatous polyp of the colon measuring >= 3 mm within the past 5 years
Screening colonoscopy performed within the past 6 months
All polyps must have been removed during colonoscopy, pathologically examined, and archived
No prior surgical resection removing > 40 cm of the colon
No personal or family history of familial polyposis or hereditary non-polyposis colon cancer
SWOG 0-1
Bilirubin = 24 months ago are allowed
No symptomatic gastric or duodenal ulcers
Not pregnant or nursing
Negative pregnancy test
Must have regional geographic stability over the next 36 months
Pure tone audiometry evaluation normal
Patients with >= 20 dB of uncorrectable hearing loss (for age) of any 2 contiguous frequencies are not allowed
No invasive malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, level I (or Breslow < 0.76 mm) cutaneous melanoma, Duke's A colon cancer, stage I cervical cancer, or stage 0 chronic lymphocytic leukemia
No severe metabolic disorder
No other significant acute or chronic disease that would preclude study participation
No history of abnormal wound healing or repair
No conditions that would confer risk of abnormal wound healing or repair
No history of allergy to NSAIDs or eflornithine
No concurrent chemotherapy
No concurrent corticosteroids on a regular or predictable intermittent basis
No concurrent radiotherapy
Concurrent calcium supplements (=< 1, 000 mg/day) allowed
Concurrent lipid-lowering drugs (i.e., high-dose statins) allowed
No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular or predictable intermittent basis
Concurrent aspirin for cardiovascular prophylaxis (i.e., 81 mg/day) allowed
No concurrent anticoagulants on a regular or predictable intermittent basis
No concurrent treatment for gastric or duodenal ulcers

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00118365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.