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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborators: |
Eli Lilly and Company Genentech |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00222729 |
Purpose
The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for another type of cancer, mesothelioma, but it is not approved for head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: Pemetrexed Drug: Bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Trial of Pemetrexed and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer |
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2005 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Main objectives of this study are to 1) evaluate the time to progression (primary endpoint) with the combination of pemetrexed and bevacizumab in recurrent or metastatic head and neck cancer; 2) evaluate the objective response rate, duration of response, overall survival, and toxicities associated with the above therapy and 3) collect tumor tissue from previous diagnostic procedures and blood specimens prospectively, before and after therapy, for future correlative studies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values:
ANC ³ 1500/mm³. Platelets ³ 100,000/mm³. Total Bilirubin within normal institutional limits.
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Hillman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15216 | |
| Principal Investigator: | Athanassios E Argiris, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Athanassios Argiris, MD/ Principal Investigator ) |
| Study ID Numbers: | 05-002, 12,158 |
| Study First Received: | September 16, 2005 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00222729 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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head neck |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bevacizumab Folic Acid Antagonists |
Angiogenesis Inhibitors Pharmacologic Actions Pemetrexed Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |