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

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

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

Conditions
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Biliary Tract Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine + Cisplatin<br>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. | Drug: gemcitabine<br>* 1000 milligrams per square meter (mg/m2), intravenous (IV)<br>* Other names: Gemzar;Drug: cisplatin<br>* 25 milligrams per square meter (mg/m2), intravenous (IV)<br>|
| Experimental: Gemcitabine<br>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. | Drug: gemcitabine<br>* 1000 milligrams per square meter (mg/m2), intravenous (IV)<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Alive at 1 Year (1-Year Survival Rate) | Percentage of patients alive at 1 year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response | Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. | baseline to measured progressive disease (up to 2 years) | 
| Progression Free Survival | The period from study entry until disease progression, death or date of last contact. | baseline to measured progressive disease (up to 2 years) |