Know Cancer

or
forgot password

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


Phase 2
40 Years
80 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

To measure the efficacy of DFMO plus Sulindac versus placebo in modulating biomarkers of colorectal neoplasia.

Outcome Time Frame:

36 months post-randomization

Safety Issue:

No

Principal Investigator

Frank L. Meyskens, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067922

NCT ID:

NCT00005882

Start Date:

June 2000

Completion Date:

December 2011

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Veterans Affairs Medical Center - Loma Linda (Pettis)Loma Linda, California  92357