NCT00832689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

January 29, 2009

Last Update Submit

March 25, 2011

Conditions

Biliary Tract Cancer

Keywords

toxicity

Study Arms (1)

1

EXPERIMENTAL
Drug: Irinotecan and Gemcitabine

Interventions

Irinotecan and GemcitabineDRUG
1

Eligibility Criteria

Age17 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 120750, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

IrinotecanGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jeong Youp Park, MD

    Assistant professor of division of Gastroenterology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

June 1, 2008

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

KR(1)