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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Biliary Tract Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gemcitabine

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B9E-KL-S292

Identifier Type: -

Identifier Source: secondary_id

6689