Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

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.

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