Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

Tracking Information
First Submitted Date ICMJE	November 1, 1999
First Posted Date ICMJE	April 30, 2004
Last Update Posted Date	July 6, 2016
Study Start Date ICMJE	March 1998
Actual Primary Completion Date	March 2001 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 14, 2015)	objective tumor response rate [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00003276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 14, 2015)	overall survival [ Time Frame: Up to 5 years ]; time to progression [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Official Title ICMJE	A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors
Brief Summary	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Gallbladder Cancer
Intervention ICMJE	Drug: irinotecan hydrochloride
Study Arms	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.; Intervention: Drug: irinotecan hydrochloride
Publications *	Alberts SR, Fishkin PA, Burgart LJ, Cera PJ, Mahoney MR, Morton RF, Johnson PA, Nair S, Goldberg RM; North Central Cancer Treatment Group. CPT-11 for bile-duct and gallbladder carcinoma: a phase II North Central Cancer Treatment Group (NCCTG) study. Int J Gastrointest Cancer. 2002;32(2-3):107-14.; Fishkin P, Alberts S, Mahoney M, et al.: Irinotecan (CPT-11) in patients (Pts) with advanced gallbladder (GB) Carcinoma (CA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-618, 2001.; Alberts S, Mahoney M, Fishkin P, et al.: Toxicity of irinotecan (CPT-11) in patients (PTS) with advanced gallbladder (GB) or biliary (BILI) tumors: a North Central Cancer Treatment Group (NCCTG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-1166, 2000.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 8, 2007)	40
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	March 2001
Actual Primary Completion Date	March 2001 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00003276
Other Study ID Numbers ICMJE	NCCTG-964252; CDR0000066181 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Alliance for Clinical Trials in Oncology
Study Sponsor ICMJE	Alliance for Clinical Trials in Oncology
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Steven R. Alberts, MD Mayo Clinic
PRS Account	Alliance for Clinical Trials in Oncology
Verification Date	July 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP