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Sponsors and Collaborators: |
University of California, San Francisco Genentech |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00187486 |
The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who have recently undergone surgery and who have not been treated with radiation therapy or chemotherapy. This is called a phase II study. The purpose of the phase II study is to determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva. There is no “placebo” drug.
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Multiforme Gliosarcoma |
Drug: Tarceva Drug: Temodar Procedure: Radiation Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Tarceva Plus Temodar During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme and Gliosarcoma |
Estimated Enrollment: | 60 |
Study Start Date: | August 2004 |
This is a Phase II Study of Tarceva plus Temodar during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma. The efficacy and safety profile of Tarceva in combination with radiation therapy plus Temodar will be studied. In addition, correlations between response to treatment and EGFR status as well as other molecular markers of tumor prior to treatment will be explored. Patients will be stratified according to EIAED use. Group A (not on EIAEDs) will take 100mg Tarceva/day during radiotherapy and start with a dose of 150 mg Tarceva/day two weeks after radiotherapy. Group B (on EIAEDs) will take 200mg Tarceva/day during radiotherapy and start with a dose of 300 mg Tarceva/day two weeks after radiotherapy. Both groups will take 75 mg/m2 Temodar/day during radiotherapy and 200 mg/m2 Temodar/day x 5 two weeks after radiotherapy. Intrapatient Tarceva dose escalation may occur every two weeks after radiotherapy until the appearance of a particular rash severity. The maximum dose allowed is 200 mg for group A and 500 mg for group B.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSF Department of Neurological Surgery | |
San Francisco, California, United States, 94143-0372 |
Principal Investigator: | Michael Prados, MD | UCSF Department of Neurological Surgery |
Study ID Numbers: | CC 04101, OSI 2725s, OTRT |
Study First Received: | September 13, 2005 |
Last Updated: | March 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00187486 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Multiforme Gliosarcoma GBM GS |
Tarceva Temodar Radiation Newly Diagnosed |
Erlotinib Neuroectodermal Tumors Brain Neoplasms Glioblastoma Glioblastoma multiforme Astrocytoma |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue |
Enzyme Inhibitors Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Protein Kinase Inhibitors Alkylating Agents Pharmacologic Actions |