Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract C... | NCT00832689

Studies
Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

NCT00832689

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Mar 28, 2011Estimated

Enrollment

39Actual

Phase

Phase 2

Conditions

Biliary Tract Cancer

Interventions

Irinotecan and Gemcitabine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 29, 2009

First Submission Date that Met QC Criteria

Jan 29, 2009

First Posted Date

Jan 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2011

Last Update Posted Date

Mar 28, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: Irinotecan and Gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
Irinotecan and Gemcitabine	Drug		1

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeong Youp Park, MD	Assistant professor of division of Gastroenterology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance hospital		Seoul		120750	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001661	Biliary Tract Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077146	Irinotecan
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D003841	Deoxycytidine

Browse Leaves

Not provided

Browse Branches

Not provided