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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Genentech |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00469469 |
This is a Phase II study of intravenous Bevacizumab in patients with pathologically confirmed nonresectable primary adrenocortical cancer (ACC). Patients must have received no prior therapy. They will receive Bevacizumab as a single agent every 2 weeks intravenously until disease progression. This study will be open at multiple sites.
Condition | Intervention | Phase |
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Adrenocortical Carcinoma |
Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Bevacizumab in Patients With Nonresectable Cancer of the Adrenal Cortex. |
Estimated Enrollment: | 24 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | September 2009 |
Adrenocortical carcinoma(ACC)is a rare malignancy with an incidence of 1.5 to 2 per million per year in the United states. Surgery is the only therapeutic option that can prolong survival. Currently there are no therapies that have been proven to prolong survival for patients with nonsurgically resectable disease. ACC has been shown to be highly resistant to standard chemotherapy, therefore, it is important that we test agents with mechanisms of action. This is a single arm phase II study of Bevacizumab, an angiogenesis inhibitor, given as a single agent at 10 mg/kg IV every 2 weeks in patients with unresectable ACC. Bevicizumab will be used as first line therapy. The study will test if Bevacizumab will be able to prolong the time to progression. If a delay in time to progression of 4 months or greater is seen, this will be considered clinically meaningful and further studies will be considered. This study will be conducted at multiple institutions (see below).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 |
Principal Investigator: | Vivek Samnotra, MD | Dartmouth-Hitchcock Medical Center |
Study ID Numbers: | DMS 0510 |
Study First Received: | May 2, 2007 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00469469 |
Health Authority: | United States: Food and Drug Administration |
Adrenal Cortex ACC |
Adrenocortical Carcinoma Adrenocortical carcinoma Adrenal Gland Diseases Endocrine System Diseases Bevacizumab Carcinoma Adrenal Gland Neoplasms |
Adrenal Cortex Neoplasms Endocrinopathy Epinephrine Adenocarcinoma Adrenal Cortex Diseases Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |