Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed cancer in the pelvis
• •Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy)
• •* Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints)
• •* Portions of rectum may have special blocking depending on disease site
• •* Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy)
• •* No planned split-course radiotherapy
• •* No planned interstitial brachytherapy prior to completion of external-beam radiotherapy
• •* Planned intracavitary radiotherapy allowed
• •* No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin
• •* Entered on study before the third radiotherapy fraction
• •No current or prior metastases beyond pelvic or para-aortic lymph nodes
• •No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy
• •No incontinence of stool
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2
• •Renal:
• •No chronic renal failure
• •Creatinine less than 2 times upper limit of normal (for patients with history of renal disease)
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No known allergy to octreotide
• •No history of inflammatory bowel disease
• •No other concurrent medical condition that would preclude study participation
• •No history of cholecystitis unless prior cholecystectomy
• •PRIOR CONCURRENT THERAPY:
• •Radiotherapy:
• •See Disease Characteristics
• •No prior radiotherapy to the pelvis
• •Surgery:
• •See Disease Characteristics
• •No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum