search
Back to results

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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer focused on measuring toxicity

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 29, 2009
Last Updated
March 25, 2011
Sponsor
Yonsei University
search

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

We'll reach out to this number within 24 hrs