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

You may be eligible if

• 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