Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003276
Recruitment Status : Completed
First Posted : April 30, 2004
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gallbladder Cancer
Intervention  ICMJE Drug: irinotecan hydrochloride
Study Arms  ICMJE 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 *

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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