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

NCT00490399 | Completed Phase 2

• 2 other identifiers: 6689B9E-KL-S292
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the response rate

Secondary Outcomes (2)

• To characterize the quantitative and qualitative toxicities of gemcitabine combined with cisplatin in this patient population.

• To evaluate the following time-to-event efficacy variables: Duration of response, Time to treatment failure, Time to documented disease progression, Overall survival

Interventions

gemcitabine DRUG

cisplatin DRUG

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Interventions

Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: March 1, 2003
• Study Completion: September 1, 2004
• Last Updated: June 22, 2007

Record last verified: 2007-06

Locations

KR (1)