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Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas

NCT00532441 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-02-12

Study results available
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Summary

An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be assessed in this trial.

Conditions

Interventions

DRUG

Erlotinib

Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28

DRUG

Docetaxel

Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • Gabi Chiorean, MD

    lead OTHER

Principal Investigators

  • Elena Gabriela Chiorean, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00532441 on ClinicalTrials.gov