RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Glutamine may be an effective treatment for acute diarrhea caused by radiation therapy. It is not known if glutamine is an effective treatment for acute diarrhea caused by radiation therapy.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of glutamine in preventing acute diarrhea in patients who have pelvic cancer and who are receiving radiation therapy.

Condition	Treatment or Intervention	Phase
Pancreatic Cancer Vulvar Cancer Renal Cell Cancer Endometrial Cancer Testicular Cancer ovarian epithelial cancer Colon Cancer Rectal Cancer uterine sarcoma Gastric Cancer adult soft tissue sarcoma Colorectal Cancer ovarian sarcoma Bladder Cancer Prostate Cancer Cervical Cancer Vaginal Cancer kidney tumor	Drug: glutamine	Phase III

Further Study Details: 

OBJECTIVES: I. Determine whether glutamine is effective in reducing the acute treatment related diarrhea in patients receiving pelvic external beam radiation therapy as adjuvant or primary treatment of malignancy.

II. Determine whether glutamine can reduce chronic treatment related enteropathy following completion of therapy.

III. Determine whether glutamine causes any toxicity in this situation.

IV. Provide initial reliability and validity data for a patient bowel function questionnaire.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are stratified by history of anterior resection of the rectum (yes vs no); total planned cumulative dose, including boost fields of external beam radiotherapy (4500-5350 cGy vs 5350-6000 cGy vs greater than 6000 cGy); use of fluorouracil (none vs bolus vs continuous infusion); and primary site (rectal cancer vs prostate cancer vs gynecological cancer vs other).

Beginning the first or second day of radiotherapy, patients receive either oral glutamine or a placebo twice daily, including the days that they do not receive radiotherapy. Patients continue on treatment throughout radiotherapy and continue 2 weeks postradiotherpy or until grade 3 diarrhea occurs.

Patients are followed weekly for 4 weeks, then at 12 months, and then at 24 months after radiotherapy.

PROJECTED ACCRUAL: A minimum of 120 fully evaluable patients (60 in each arm) will be accrued in one year.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed pelvic cancer
• Planned therapy is to undergo continuous definitive or adjuvant external beam pelvic radiation therapy with or without fluorouracil (5-FU) plus or minus levamisole; No split course radiation therapy
• Planned course of radiation therapy must also meet the following criteria: Entire pelvis must be encompassed by the planned radiotherapy fields; Total planned dose to the central axis midplane or isocenter for the whole pelvic field must be between 4500-5350 cGy; Treatment must be given 4-5 times per week on a one-treatment-per-day basis
• No stool incontinence or stool frequency of 7 or more per day prior to initiation of radiation therapy
• Must be entered on study before the second radiation therapy fraction
• No current or prior metastases beyond pelvic regional lymph nodes
• Must have functioning rectum; No planned perineal irradiation; No anal cancer
• No active intraluminal gastrointestinal (GI) tumors; Patients with completely resectioned GI tumors who also receive adjuvant treatment are eligible

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No concurrent leucovorin or other chemotherapy agents, except 5-FU with or without levamisole
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; No prior pelvic radiotherapy; No brachytherapy prior to completion of all external beam radiotherapy
• Surgery: No abdominal-perineal resection, Hartmann procedure, or other surgical procedure that has left patient without a functioning rectum

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Creatinine less than 2 times upper limit of normal
• Other: No known allergy to glutamine; No history of inflammatory bowel disease; No other medical condition that may interfere with treatment; Not pregnant or nursing; Adequate contraception is required of all fertile patients

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  10309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Quain & Ramstad Clinic, P.C., Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      CCOP - Geisinger Clinical and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
Canada, Saskatchewan
      Saskatchewan Cancer Agency, Regina,  Saskatchewan,  S4S 6X3,  Canada

Study chairs or principal investigators

Timothy Frank Kozelsky,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000065974; NCCTG-969256; NCI-P97-0127
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003170
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08