Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
Primary Purpose
Biliary Tract Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Irinotecan and Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring toxicity
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed inoperable biliary tract cancer
- Age: 18 ~75 years old
- Performance status: ECOG 0-2
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin No greater than 2 fold the upper normal limit
- AST/ALT : No greater than 3 fold the upper normal limit
Renal:
- Creatinine - no greater than 1.5 mg/dL
- Not pregnant
- No other serious medical or psychiatric illness that would preclude giving informed consent or limit
- No prior chemotherapy within 6 months
- No other concurrent anticancer radiotherapy within 6 months
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00832689
Brief Title
Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
Brief Summary
The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Irinotecan and Gemcitabine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed inoperable biliary tract cancer
Age: 18 ~75 years old
Performance status: ECOG 0-2
Hematopoietic:
Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin No greater than 2 fold the upper normal limit
AST/ALT : No greater than 3 fold the upper normal limit
Renal:
Creatinine - no greater than 1.5 mg/dL
Not pregnant
No other serious medical or psychiatric illness that would preclude giving informed consent or limit
No prior chemotherapy within 6 months
No other concurrent anticancer radiotherapy within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Youp Park, MD
Organizational Affiliation
Assistant professor of division of Gastroenterology
Official's Role
Study Director
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120750
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
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