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Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

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

Condition Intervention Phase
Biliary Tract Cancer
Drug: Irinotecan and Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Enrollment: 39
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Irinotecan and Gemcitabine


Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00832689

Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120750
Sponsors and Collaborators
Yonsei University
Study Director: Jeong Youp Park, MD Assistant professor of division of Gastroenterology
  More Information

Responsible Party: Seung Woo Park, Professor, Severance hospital Identifier: NCT00832689     History of Changes
Other Study ID Numbers: 4-2007-0191 
Study First Received: January 29, 2009
Last Updated: March 25, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on October 28, 2016