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Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

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ClinicalTrials.gov Identifier: NCT00832689
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : March 28, 2011
Sponsor:
Information provided by:
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Irinotecan and Gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Primary Purpose: Treatment
Study Start Date : June 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010


Arm Intervention/treatment
Experimental: 1 Drug: Irinotecan and Gemcitabine




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Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Seung Woo Park, Professor, Severance hospital
ClinicalTrials.gov Identifier: NCT00832689     History of Changes
Other Study ID Numbers: 4-2007-0191
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011

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
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