MedTrace Logo

Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy

NCT00919061 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-02-03

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers.

Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. We are looking to improve treatment results. We will attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan. Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the cancer cells grow and divide. This study will help answer the question of whether sorafenib is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.

This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile duct and gallbladder cancers.

Conditions

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer

Interventions

DRUG

Gemcitabine

Gemcitabine: 800 mg/m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.

DRUG

Cisplatin

20 mg /m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.

DRUG

Sorafenib

400 mg PO once a day continuously.

Sponsors & Collaborators

Principal Investigators

  • Ghassan Abou-Alfa, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00919061 on ClinicalTrials.gov