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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00979017 |
Purpose
The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate and progression-free survival. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients.
This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal WHO grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.
In initial Phase I and II clinical trials, 4 potential Avastin-associated safety signals were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. Temozolomide's most common toxicity has been mild myelosuppression. Other, less likely, potential toxicities include nausea and vomiting, constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy, and hepatotoxicity. The two major toxicities for irinotecan are myelosuppression and diarrhea.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme Gliosarcoma |
Drug: Avastin in combination with temozolomide and irinotecan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Avastin in Combination With Temozolomide and Irinotecan for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas |
| Estimated Enrollment: | 41 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2012 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Avastin-specific Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | James J Vredenburgh, MD | Duke University |
More Information
| Responsible Party: | James J. Vredenburgh, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00979017 History of Changes |
| Other Study ID Numbers: | Pro00019065 |
| Study First Received: | September 15, 2009 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
malignant glioma glioblastoma multiforme gliosarcoma Avastin bevacizumab Temodar |
temozolomide Irinotecan CPT-11 Pro00019065 Vredenburgh Duke |
|
Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Dacarbazine Irinotecan Bevacizumab |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |