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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
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832689

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

No publications provided

Responsible Party: Seung Woo Park, Professor, Severance hospital
ClinicalTrials.gov 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:
toxicity

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013