Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer

Brief Title

Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer

Official Title

A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer

Brief Summary

      To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine
      alone by comparison in patients with advanced biliary tract cancer
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Percentage of Patients Alive at 1 Year (1-Year Survival Rate)

Secondary Outcome

 Tumor Response

Condition

Biliary Tract Cancer

Intervention

gemcitabine

Study Arms / Comparison Groups

 Gemcitabine + Cisplatin

Description:  Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

84

Start Date

September 2006

Completion Date

October 2008

Primary Completion Date

October 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Histological or cytological diagnosis of biliary tract cancer

          -  Measurable disease must be at least one lesion

          -  Chemotherapy-naïve

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Estimated life expectancy no less than 3 months

        Exclusion Criteria:

          -  radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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), , 

Location Countries

Japan

Location Countries

Japan

NCT ID

NCT00380588

Organization ID

10298

Secondary IDs

B9E-JE-BT22

Study Sponsor

Eli Lilly and Company

Study Sponsor

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), Study Director, Eli Lilly and Company

Verification Date

November 2009