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Trial of Gemcitabine and Cisplatin in Patients With Inoperable Biliary Tract Carcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00490399
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : June 22, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the efficacy of gemcitabine and cisplatin in Korean patients with biliary tract (bile tracts of the gallbladder or liver) cancer.

Condition or disease Intervention/treatment Phase
Biliary Tract Carcinoma Drug: gemcitabine Drug: cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of GEMZAR Combined With Cisplatin in Patients With Inoperable Biliary Tract Carcinomas
Study Start Date : March 2003
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To evaluate the response rate

Secondary Outcome Measures :
  1. To characterize the quantitative and qualitative toxicities of gemcitabine combined with cisplatin in this patient population.
  2. To evaluate the following time-to-event efficacy variables: Duration of response, Time to treatment failure, Time to documented disease progression, Overall survival


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic diagnosis of adenocarcinoma of the gallbladder, intra/extrahepatic bile ducts or papilla of Vater with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy.
  • Disease status must be measurable disease defined as: Bi-dimensionally measurable lesions with clearly defined margins and two perpendicular diameters that are clearly measurable by following:

    • Computerized tomography (CT) or magnetic resonance imaging (MRI), with one diameter 2.0 cm or greater and the other diameter 1.0 cm or greater.
    • Palpable Lesion, with both diameters 2 cm or greater. Disease progressing in areas of prior radiation therapy may be included.
  • Patients must have received no prior chemotherapy for advanced disease.
  • Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

  • Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment
  • Severe neurological or mental disorder.
  • Active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy.
  • Poorly controlled diabetes mellitus.

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): NCT00490399


Locations
Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, Korea, Republic of
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
ClinicalTrials.gov Identifier: NCT00490399     History of Changes
Other Study ID Numbers: 6689
B9E-KL-S292
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: June 22, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs