Clinical trial NCT00380588: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
timeFrame: 1 year
Secondary outcomes:
measure: Tumor Response
timeFrame: baseline to measured progressive disease (up to 2 years)
measure: Progression Free Survival
timeFrame: baseline to measured progressive disease (up to 2 years)
Other outcomes:
measure: Survival Time
timeFrame: baseline to date of death due to any cause (up to 2 years)
Locations:
city: Aichi
country: Japan
facility: 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.
city: Chiba
country: Japan
facility: 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.
city: Fukuoka
country: Japan
facility: 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.
city: Hokkaido
country: Japan
facility: 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.
city: Kanagawa
country: Japan
facility: 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.
city: Shizuoka
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: