Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: eflornithine (Drug); sulindac (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Chao Family Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Frank L. Meyskens, MD, FACP, Study Chair, Affiliation: Chao Family Comprehensive Cancer Center
Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of eflornithine and sulindac may be an effective
way to prevent the development of colorectal cancer in patients who have had surgery to
remove benign colorectal polyps.
PURPOSE: Randomized, double-blinded, phase II trial to determine the effectiveness of
eflornithine plus sulindac compared to a placebo in preventing colorectal cancer in patients
who have had surgery to remove benign colorectal polyps.
Clinical Details
Official title: A Phase II Clinical Trial of a Randomized, Double-Blind, Placebo Controlled Clinical Trial of DFMO and Sulindac Against Various Endpoints of Colorectal Pathobiology in a Cohort of Individuals at Increased Risk of Colorectal Carcinoma
Study design: Prevention, Randomized, Double-Blind, Active Control
Detailed description:
OBJECTIVES:
- Compare the efficacy of eflornithine (DFMO) and sulindac vs placebo in modulating a
panel of surrogate endpoint biomarkers (SEB) of particular relevance in colorectal
neoplasia, including quantitative histopathology, uninduced apoptosis, proliferative
(Ki67) and preneoplastic (CEA, sialyl-TN, p53, and bcl-2) features, and polyamine and
PGE2 levels in patients with at least one previously resected colorectal adenoma.
- Determine the relationship between the modulation of SEB in flat mucosa and the
development of interval incident colorectal adenomas in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to aspirin use (yes vs no) and participating center.
Patients receive oral placebo daily for the first 4 weeks. Patients who are compliant and
take the placebo 5 to 7 days each week are randomized to one of two treatment arms.
- Arm I: Patients receive oral sulindac and oral eflornithine (DFMO) daily.
- Arm II: Patients receive oral placebo daily. Treatment continues for 3 years in the
absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 240 patients (120 per treatment arm) will be accrued for
this study within 18 months.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- At least 1 prior resected colorectal adenoma within the past 5 years
- At least 3 mm in size
- No personal or family history of familial adenomatous polyposis
PATIENT CHARACTERISTICS:
Age:
- 40 to 80
Performance status:
- SWOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Hematocrit at least 35%
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2. 0 mg/dL
- AST and ALT no greater than 2 times normal
Renal:
- Creatinine no greater than 1. 5 mg/dL
- No greater than 1+ protein, 0-3 casts, and 0-5 WBCs and RBCs in urine
Gastrointestinal:
- No requirement for special diet or additives
- No diet that would preclude taking study medications
- No gastric or duodenal ulcer within the past year
- No inflammatory bowel disease
Other:
- No more than 20 dB hearing loss for age at any frequency
- No prior or concurrent invasive cancer within the past 5 years except nonmelanomatous
skin cancer, melanoma in situ, stage I cervical cancer, stage I colon cancer, or stage
0 chronic lymphocytic leukemia
- No severe metabolic disorder or other acute or chronic diseases
- No history of or predisposition to abnormal wound healing or repair
- No allergies to nonsteroidal anti-inflammatories or eflornithine
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No other concurrent nonsteroidal anti-inflammatories or anticoagulants administered on
a regular or predictable intermittent basis
- No concurrent aspirin greater than 81 mg per day or 325 mg twice a week for
cardiovascular disease prophylaxis
- No concurrent calcium supplements greater than 500 mg/day
Locations and Contacts
Arizona Cancer Center, Tucson, Arizona 85724-5024, United States
Chao Family Comprehensive Cancer Center, Orange, California 92868, United States
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California 92357, United States
University of Colorado Cancer Center, Denver, Colorado 80010, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2000
Last updated: May 23, 2008
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