MedTrace Logo

A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer

NCT00955721 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-01-03

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.

Conditions

Interventions

DRUG

Gemcitabine

Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.

DRUG

Oxaliplatin

Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.

DRUG

Sorafenib

Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Peter Hosein, MD · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00955721 on ClinicalTrials.gov