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Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
This study is ongoing, but not recruiting participants.
First Received: July 8, 2005   Last Updated: May 12, 2009   History of Changes
Sponsor: Chao Family Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118365
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Colorectal Cancer
Precancerous/Nonmalignant Condition
Drug: eflornithine
Drug: sulindac
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of new adenomatous polyp formation [ Designated as safety issue: No ]
  • Effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa [ Designated as safety issue: No ]
  • Side effects of treatment [ Designated as safety issue: Yes ]

Study Start Date: June 2005
Detailed Description:

OBJECTIVES:

  • Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.
  • Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients.
  • Compare the rate of side effects in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).

Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral double placebo once daily.
  • Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

PROJECTED ACCRUAL: A total of 150 additional patients (124 randomized) will be accrued for this study within 18 months.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 40 to 80

Performance status

  • SWOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Hematocrit ≥ 35%
  • WBC ≥ 4,000/mm³
  • Platelet count ≥ 100,000/mm³

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2 times normal

Renal

  • Creatinine ≤ 1.5 mg/dL
  • Urine protein ≤ 1+*
  • Urine casts 0-3*
  • Urine WBC and RBC count 0-5 cells* NOTE: *By urinalysis

Gastrointestinal

  • No history of inflammatory bowel disease
  • No gastric or duodenal ulcers within the past 12 months

    • Gastric or duodenal ulcers that were adequately treated > 24 months ago are allowed
  • No symptomatic gastric or duodenal ulcers

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent corticosteroids on a regular or predictable intermittent basis

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Concurrent calcium supplements (≤ 1,000 mg/day) allowed
  • Concurrent aspirin for cardiovascular prophylaxis (i.e., 81 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
  • No concurrent anticoagulants on a regular or predictable intermittent basis
  • No concurrent treatment for gastric or duodenal ulcers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118365

Locations
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, United States, 92357
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
United States, Colorado
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-6616
Australia, South Australia
Flinder Medical Centres
Bedford Park, South Australia, Australia, 5042
Sponsors and Collaborators
Chao Family Comprehensive Cancer Center
Investigators
Principal Investigator: Frank L. Meyskens, MD, FACP Chao Family Comprehensive Cancer Center
Principal Investigator: Eugene Gerner, PhD University of Arizona
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000429552, UCIRVINE-UCI-2002-2261
Study First Received: July 8, 2005
Last Updated: May 12, 2009
ClinicalTrials.gov Identifier: NCT00118365     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer
precancerous/nonmalignant condition

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Trypanocidal Agents
Anti-Infective Agents
Antiprotozoal Agents
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Colonic Diseases
Rectal Diseases
Antiparasitic Agents
Neoplasms by Site
Sensory System Agents
Eflornithine
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Digestive System Neoplasms
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Sulindac

ClinicalTrials.gov processed this record on February 08, 2010