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

Phase 2

Completed

• Conditions: Biliary Tract Cancer
• Interventions: Drug: gemcitabine; Drug: cisplatin

• Registration Number: NCT00380588
• Lead Sponsor: Eli Lilly and Company

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-22
• Study First Submitted QC: 2006-09-22
• Study First Posted: 2006-09-26
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-10-15
• Results First Submitted QC: 2009-10-15
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-18
• Results First Posted: 2009-11-19
• Last Update Posted: 2009-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine + Cisplatin	gemcitabine	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.
Gemcitabine + Cisplatin	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.
Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Alive at 1 Year (1-Year Survival Rate)	1 year	Percentage of patients alive at 1 year.

Secondary Outcome Measures

Name	Time	Method
Tumor Response	baseline to measured progressive disease (up to 2 years)	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.
Progression Free Survival	baseline to measured progressive disease (up to 2 years)	The period from study entry until disease progression, death or date of last contact.

Trial Locations

Locations (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.; 🇯🇵 Tokyo, Japan