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

Inclusion Criteria

• •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