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Sponsored by: |
Ohio State University Comprehensive Cancer Center |
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Information provided by: | Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00201838 |
The aims of this protocol are:
Condition | Intervention | Phase |
---|---|---|
Pancreatic Neoplasms Adenocarcinoma |
Drug: Etanercept Drug: Gemcitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma |
Estimated Enrollment: | 40 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | November 2006 |
Rationale: The standard treatment for pancreatic cancer is gemcitabine. This study combines gemcitabine with etanercept, a drug that binds with tumor necrosis factor (TNF) molecules and blocks their activity through inhibiting their interaction with cell surface TNF receptors. TNF is the name for a protein in the body that often helps fight foreign substances. However, research suggests that pancreatic tumors develop resistance to TNF and then use it to support cancer growth. Combining etanercept, a TNF inhibitor, with gemcitabine is a novel approach to advanced pancreatic cancer. Because etanercept has not been tested in combination with gemcitabine, a Phase I study will be conducted first to identify the safest dosage of etanercept, and then a Phase II study will evaluate the efficacy of this combination.
Purpose: This study is evaluating the safety of etanercept and gemcitabine for advanced pancreatic cancer in Phase I, and the efficacy of etanercept and gemcitabine for this condition in Phase II. TNF and other inflammatory markers will also be measured in the study.
Treatment: Patients in this study will receive gemcitabine and etanercept. Gemcitabine will be administered through an intravenous infusion weekly for seven weeks followed by one week of rest. Additional treatments with gemcitabine will be given for three weeks followed by one week of rest. Patients will administer etanercept to themselves through a small injection underneath the skin twice each week. Six patients will initially be enrolled in Phase I. If severe side effects appear in at least two patients in Phase I, then additional patients will be enrolled and treated with lower dosages of gemcitabine. When the treatments do not produce unacceptable side effects, the Phase I portion of the study will end and Phase II will begin enrolling patients. Patients in the Phase II portion of the study will also receive gemcitabine and etanercept at the safest dosages identified in Phase I. Several tests and exams will be given throughout both portions of the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Miguel Villalona | Ohio State University |
Study ID Numbers: | OSU-0041 |
Study First Received: | September 12, 2005 |
Last Updated: | December 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00201838 |
Health Authority: | United States: Food and Drug Administration |
Advanced Stage Chemotherapy Naive |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases TNFR-Fc fusion protein Carcinoma Digestive System Diseases Gastrointestinal Neoplasms |
Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Neoplasms by Histologic Type Gastrointestinal Agents Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |