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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

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

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00832689

First Posted

January 29, 2009

Last Updated

March 25, 2011

Sponsor

Yonsei University

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

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

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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