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

Biliary Tract Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490399
• Other study ID #: 6689
• Secondary ID: B9E-KL-S292
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: March 2003
• Est. completion date: September 2004

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Carcinoma

Intervention

Drug:
• gemcitabine

• cisplatin

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the response rate
Secondary	To characterize the quantitative and qualitative toxicities of gemcitabine combined with cisplatin in this patient population.
Secondary	To evaluate the following time-to-event efficacy variables: Duration of response, Time to treatment failure, Time to documented disease progression, Overall survival

External Links

•   Lilly Clinical Trial Registry