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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer  Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
For Condition: recurrent gallbladder cancer,unresectable gallbladder cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenAlberts, Study Chair, North Central Cancer Treatment Group
Saskatchewan Cancer Agency
Regina, Saskatchewan, S4S 6X3
Canada
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Quain & Ramstad Clinic, P.C.
Bismark, North Dakota, 58501
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Additional Information:
Study ID Numbers: CDR0000066181; NCCTG-964252
Study Start Date: March 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003276
Other Recurrent Gallbladder Cancer Studies:
1. Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
2. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
3. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
4. DX-8951f in Treating Patients With Biliary Cancer
Related Studies:
Other recurrent gallbladder cancer Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
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