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PHASE II DOUBLE-BLIND CHEMOPREVENTION TRIAL OF HIGH DOSE FOLIC ACID VERSUS PLACEBO IN PATIENTS WITH RESECTED COLORECTAL POLYPS


Phase 2
21 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

PHASE II DOUBLE-BLIND CHEMOPREVENTION TRIAL OF HIGH DOSE FOLIC ACID VERSUS PLACEBO IN PATIENTS WITH RESECTED COLORECTAL POLYPS


OBJECTIVES: I. Determine whether high-dose folic acid decreases global DNA hypomethylation,
as well as other intermediary markers, in normal-appearing colonic epithelium of patients
with colonic adenomas. II. Determine whether a decrease in global DNA hypomethylation and
other intermediary markers can be induced safely and whether these effects persist after
folic acid is discontinued in these patients. III. Confirm pilot data that indicates
patients with adenomas have widespread DNA hypomethylation of the colorectal mucosa compared
to controls. IV. Evaluate the effect of folic acid on the clinical course and rate of
recurrence of adenomatous polyps in these patients. V. Study a control group of patients
with no history of neoplastic, hyperplastic, or inflammatory colorectal lesions.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center and age (50-70 vs 30-49 and over 70).
Patients with adenomatous polyps at least 10 mm at colonoscopy are randomized to 1 of 2
treatment arms. Patients found to have no neoplastic, hyperplastic, or inflammatory polyps
at colonoscopy are assigned to a control (untreated) group and complete laboratory studies
and a baseline food frequency questionnaire only. Arm I: Patients receive folic acid daily.
Arm II: Patients receive placebo daily. Treatment continues in both arms for 1 year in the
absence of unacceptable toxicity or disease progression. Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 80 patients (30 per arm and 20 for the control group) will be
accrued for this study within 24 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Colonic adenoma(s) of at least 10 mm completely resected within
18 months prior to randomization or suspected adenomatous polyp(s) Colonoscopy with
submission of at least 7 rectosigmoid biopsies required at entry No benign hyperplastic
polyps or polyps less than 10 mm to be eligible for treatment No polyposis coli (i.e.,
more than 100 polyps in colon) No history of invasive colorectal cancer

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Platelet count greater than 100,000/mm3 Hemoglobin greater
than 10 g/dL No untreated pernicious anemia Hepatic: Bilirubin less than 2 mg/dL ALT less
than 2 times normal Alkaline phosphatase less than 2 times normal PT normal Renal: Not
specified Gastrointestinal: No intestinal malabsorption No inflammatory bowel disease
Other: No seizure within the past year No poor medical risk No other malignancy within
past 5 years except basal cell cancer, superficial skin cancer, or carcinoma in situ of
the cervix No vitamin B12 deficiency (less than 200 pg/mL) Not pregnant or nursing Fertile
patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent
methotrexate Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See
Disease Characteristics No prior small bowel resection Other: No concurrent
anticonvulsants No concurrent drugs that markedly interfere with folate absorption or
metabolism (e.g., sulfasalazine and phenytoin) No concurrent vitamins during and for 2
years after beginning of study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Joel Mason, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Tufts Medical Center Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064180

NCT ID:

NCT00002650

Start Date:

April 1995

Completion Date:

Related Keywords:

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

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
USDA Human Nutrition Research CenterBoston, Massachusetts  02111