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A Phase II Trial of GEMZAR Combined With Cisplatin in Patients With Inoperable Biliary Tract Carcinomas

Phase 2
20 Years
70 Years
Not Enrolling
Biliary Tract Carcinoma

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Trial Information

A Phase II Trial of GEMZAR Combined With Cisplatin in Patients With Inoperable Biliary Tract Carcinomas

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response rate

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Korea: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

September 2004

Related Keywords:

  • Biliary Tract Carcinoma
  • Carcinoma