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.

Condition	Treatment or Intervention	Phase
recurrent gallbladder cancer unresectable gallbladder cancer	Drug: irinotecan	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      Altru Health Systems, Grand Forks,  North Dakota,  58201,  United States
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Quain & Ramstad Clinic, P.C., Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Canada, Saskatchewan
      Saskatchewan Cancer Agency, Regina,  Saskatchewan,  S4S 6X3,  Canada

Study chairs or principal investigators

Steven R. Alberts,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000066181; NCCTG-964252
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003276
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08