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Sponsors and Collaborators: |
University of Cincinnati Sanofi-Aventis |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00728000 |
The goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy.
Condition | Intervention | Phase |
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Pancreatic Adenocarcinoma |
Drug: Gemcitabine Drug: Oxaliplatin Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma |
Estimated Enrollment: | 20 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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chemotherapy regimen: Experimental
Gemcitabine and oxaliplatin are given intravenously (into the vein) every 2 weeks. Erlotinib is a pill that is taken by mouth daily.
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Drug: Gemcitabine
Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins.
Drug: Oxaliplatin
100mg/m2 IV on days 1 and 15 given over 120 mins.
Drug: Erlotinib
100mg/day PO on days 1-14 and 15-28
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Although surgery is the only curative modality for pancreatic adenocarcinoma, the majority of patients (~80%)are unresectable at presentation. The use of a multimodality approach may be a crucial method to improve the dismal survival rate of patients with pancreatic cancer. A logical tactic is to use neoadjuvant cytotoxic agents and targeted drugs to facilitate resectability.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
Contact: Tammy Roads | 513-558-2192 | roadst@ucmail.uc.edu |
Contact: Malek Safa, MD | 513-584-5802 | malek.safa@uc.edu |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 |
Principal Investigator: | Malek Safa, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Malek Safa, MD ) |
Study ID Numbers: | OX-06-030, OX-06-030 |
Study First Received: | July 31, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00728000 |
Health Authority: | United States: Institutional Review Board |
Pancreatic Cancer |
Erlotinib Oxaliplatin Pancreatic Neoplasms Gemcitabine |
Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses |