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Sponsors and Collaborators: |
Hoosier Oncology Group Sanofi-Aventis OSI Pharmaceuticals |
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Information provided by: | Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00532441 |
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.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma Biliary Tract Carcinoma |
Drug: Erlotinib Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101 |
Estimated Enrollment: | 39 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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
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Outline: This is a multi-center study.
Patients who meet eligibility criteria will receive treatment as follows until disease progression or excessive toxicities:
Treatment cycle = 28 days
Performance Status: ECOG performance status 0 to 2
Life expectancy: At least 12 weeks
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elena Gabriela Chiorean, M.D. | 317-278-6942 | gchiorea@iupui.edu |
Contact: Jayme Harvey | 317-921-2050 | harveyj@iupui.edu |
United States, Indiana | |
Indiana University Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Elena Gabriela Chiorean, M.D. 317-278-6942 gchiorea@iupui.edu | |
Contact: Kerry Bridges 317-274-2552 kdbridge@iupui.edu |
Study Chair: | Elena Gabriela Chiorean, M.D. | Hoosier Oncology Group, LLC |
Responsible Party: | Hoosier Oncology Group ( Elena Gabriela Chiorean, M.D. ) |
Study ID Numbers: | GI06-101 |
Study First Received: | September 18, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00532441 |
Health Authority: | United States: Institutional Review Board |
Erlotinib Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Carcinoma Liver Neoplasms |
Docetaxel Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |