Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Gallbladder Cancer
About this trial
This is an interventional treatment trial for Gallbladder Cancer focused on measuring unresectable gallbladder cancer, recurrent gallbladder cancer
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
Sites / Locations
- CCOP - Scottsdale Oncology Program
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ochsner
- CCOP - Ann Arbor Regional
- Mayo Clinic Cancer Center
- CentraCare Clinic
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Quain & Ramstad Clinic, P.C.
- CCOP - Merit Care Hospital
- Altru Health Systems
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Geisinger Clinic and Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- Saskatchewan Cancer Agency
Arms of the Study
Arm 1
Experimental
irinotecan
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.