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Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Gallbladder Cancer | Drug: irinotecan hydrochloride | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors |
- objective tumor response rate [ Time Frame: Up to 5 years ]
- overall survival [ Time Frame: Up to 5 years ]
- time to progression [ Time Frame: Up to 5 years ]
| Enrollment: | 40 |
| Study Start Date: | March 1998 |
| Study Completion Date: | March 2001 |
| Primary Completion Date: | March 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: irinotecan hydrochloride |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00003276
| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CentraCare Clinic | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, North Dakota | |
| Quain & Ramstad Clinic, P.C. | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Canada, Saskatchewan | |
| Saskatchewan Cancer Agency | |
| Regina, Saskatchewan, Canada, S4S 6X3 | |
| Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
More Information
Publications:
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00003276 History of Changes |
| Other Study ID Numbers: |
NCCTG-964252 CDR0000066181 ( Registry Identifier: PDQ (Physician Data Query) ) |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 1, 2016 |
Keywords provided by Alliance for Clinical Trials in Oncology:
|
unresectable gallbladder cancer recurrent gallbladder cancer |
Additional relevant MeSH terms:
|
Gallbladder Neoplasms Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases |
Irinotecan Camptothecin Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 17, 2017