Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed primary anal or rectal cancer

• No metastasis beyond the pelvic regional nodes

• Must be scheduled to receive chemoradiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Liver function tests < 3 times upper limit of normal

• No prior hepatic disease

Renal

• Not specified

Gastrointestinal

• No prior chronic or acute regional enteritis

• No malabsorption syndrome

• No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity

• No grade 2 or greater uncontrollable diarrhea at baseline

• No prior cholecystitis or gallstones, unless a cholecystectomy has been performed

• No prior incontinence of stool

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No uncontrolled diabetes (e.g., fasting glucose > 250 mg/dL)

• No prior allergy or hypersensitivity to study drug or other related drug or compound

• No other medical condition or mental impairment that would preclude study treatment and compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• Prior chemotherapy allowed

Endocrine therapy

• At least 6 months since prior administration of any of the following:

• Glucocorticoid therapy

• Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone)

• Exogenous growth hormone therapy

Radiotherapy

• See Disease Characteristics

• No prior pelvic radiotherapy

• No prior intensity-modulated radiotherapy

• No concurrent radiotherapy for abdominal cancer

• No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy

• No brachytherapy prior to or after completion of all external beam radiotherapy

Surgery

• No prior abdominal-perineal resection or other surgical procedure leaving the patient without a functioning rectum

• No colostomy

Other

• More than 30 days since other prior investigational drugs

• No prior octreotide for cancer therapy-related diarrhea

• No concurrent prophylactic antidiarrheal medication