A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer
Overview
- Phase
- Phase 2
- Intervention
- gemcitabine
- Conditions
- Biliary Tract Cancer
- Sponsor
- Eli Lilly and Company
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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
Investigators
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
Arms & Interventions
Gemcitabine + Cisplatin
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.
Intervention: gemcitabine
Gemcitabine + Cisplatin
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.
Intervention: cisplatin
Gemcitabine
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Intervention: gemcitabine
Outcomes
Primary Outcomes
Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
Time Frame: 1 year
Percentage of patients alive at 1 year.
Secondary Outcomes
- Tumor Response(baseline to measured progressive disease (up to 2 years))
- Progression Free Survival(baseline to measured progressive disease (up to 2 years))