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A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors

Phase 2
18 Years
Open (Enrolling)
Gallbladder Cancer

Thank you

Trial Information

A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors

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

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

  • Gallbladder Cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms



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