Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Octreotide may be effective in preventing diarrhea that is caused by treatment with irinotecan.

PURPOSE: Randomized phase III trial to study the effectiveness of octreotide in preventing diarrhea in patients who are receiving irinotecan for metastatic colon cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Camptothecin; Irinotecan; Octreotide

Criteria

DISEASE CHARACTERISTICS: Histologically, cytologically, and/or radiographically proven metastatic colorectal cancer with disease recurrence or progression following fluorouracil (5-FU) based chemotherapy Acceptable 5-FU based regimens include capecitabine, 5-FU-uracil, floxuridine, S-1, or eniluracil combined with 5-FU Acceptable 5-FU modulating agents include levamisole and leucovorin calcium Measurable or evaluable disease No known brain or leptomeningeal disease except previously irradiated lesions that do not require corticosteroids and are asymptomatic

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension No unstable angina No congestive heart failure No myocardial infarction within the past 6 months No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or fibrosis Gastrointestinal: No symptomatic cholelithiasis No gastrointestinal disease that may result in nontherapy related diarrhea Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other medical or surgical disease that may result in nontherapy related diarrhea No other severe disease that would preclude study No mental incapacity or psychiatric illness that would preclude study No uncontrolled diabetes mellitus No hypersensitivity to octreotide or any of its excipients No active or uncontrolled infection HIV negative No active second malignancy within the past 5 years except nonmelanomatous skin cancer or cervical carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan At least 7 days since other prior chemotherapy and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: No ostomy Other: Greater than 1 month since prior investigational agent No concurrent investigational agent No concurrent phenytoin, phenobarbital, valproic acid, or other antiepileptic therapy