irinotecan in treating patients with advanced gallbladder or bile duct cancer

Conditions: Gallbladder Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of irinotecan in treating patients with advanced gallbladder or bile duct cancer that cannot be removed surgically.

objectives: i. evaluate the objective tumor response rate in patients with advanced gallbladder or bile duct tumors treated with irinotecan. ii. evaluate time-to-progression, survival, and toxic effects associated with irinotecan given weekly for 4 weeks every 6 weeks in this patient population. outline: patients receive a 90 minute continuous infusion of irinotecan on days 1, 8, 15, and 22 for 4 weeks, followed by a 2 week rest period. courses of treatment are repeated every 42 days. patients continue treatment in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 1 year, then every 6 months for the next 4 years. projected accrual: approximately 22-40 patients will be accrued for this study over 2-4 years.

Eligibility criteria:
disease characteristics: histologically or cytologically proven gallbladder or bile duct carcinoma with metastatic or recurrent disease deemed unresectable and not considered a candidate for potentially curative therapy measurable or evaluable disease no known active cns disease closed to bile duct carcinoma as of july 1999 patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: absolute neutrophil count at least 1500/mm3 platelet count at least 100,000/mm3 hepatic: sgot no greater than 5 times upper limit of normal (uln) bilirubin no greater than 1.5 mg/dl or bilirubin no greater than 2 times uln in patients with biliary stents or percutaneous biliary catheters renal: creatinine no greater than 1.5 mg/dl cardiovascular: no new york heart association class iii or iv heart disease other: nutritional intake at least 1200 kcal/day no uncontrolled infection or chronic debilitating disease not pregnant or nursing fertile patients must use effective contraception no uncontrolled seizure disorder no prior malignancy within 5 years except adequately treated basal cell/squamous cell carcinomas and adequately treated noninvasive carcinomas prior concurrent therapy: biologic therapy: no prior biological therapy or immunotherapy for recurrent or metastatic disease no concurrent biologic therapy chemotherapy: no prior chemotherapy for recurrent or metastatic disease prior adjuvant chemotherapy allowed if used as a radiation sensitizer for completely resected disease no other concurrent chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy for recurrent or metastatic disease prior adjuvant radiotherapy allowed if used as a radiation sensitizer for completely resected disease no radiotherapy to greater than 25% of bone marrow no radiotherapy within the past 4 weeks no concurrent radiotherapy concurrent cns radiation allowed surgery: no post abdominal exploration (with or without resection) within the past 4 weeks other: no concurrent medication for other medical conditions except for: analgesics chronic treatments for preexisting conditions agents required for life-threatening medical conditions no laxatives

Keywords: unresectable gallbladder cancer recurrent gallbladder cancer