Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00832689
First received: January 29, 2009
Last updated: March 25, 2011
Last verified: March 2011

January 29, 2009
March 25, 2011
June 2008
February 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00832689 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
Not Provided

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.

Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
Biliary Tract Cancer
Drug: Irinotecan and Gemcitabine
Experimental: 1
Intervention: Drug: Irinotecan and Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
17 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00832689
4-2007-0191
Not Provided
Seung Woo Park, Professor, Severance hospital
Yonsei University
Not Provided
Study Director: Jeong Youp Park, MD Assistant professor of division of Gastroenterology
Yonsei University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP