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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis Genentech |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00607113 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
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Neuroendocrine Carcinoma |
Drug: Avastin Drug: RAD001 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Exploratory Study of Avastin (Bevacizumab) and RAD001 (Everolimus) in Advanced Low or Intermediate Grade Neuroendocrine Carcinoma (AVF3961s) (CRAD001C2481) |
Estimated Enrollment: | 36 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Avastin: Experimental
Cycle 1 (First 3 weeks of study).
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Drug: Avastin
15 mg/kg By Vein Over 90 Minutes Every 21 Days
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Avastin + RAD001: Experimental
Cycle 2 +
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Drug: Avastin
15 mg/kg By Vein Over 90 Minutes Every 21 Days
Drug: RAD001
10 mg By Mouth Daily For 21 Days
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RAD001: Experimental
Cycle 1 (First 3 weeks of study).
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Drug: RAD001
10 mg By Mouth Daily For 21 Days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | James Yao, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( James Yao, MD/Associate Professor ) |
Study ID Numbers: | 2006-0954 |
Study First Received: | January 22, 2008 |
Last Updated: | June 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00607113 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Neuroendocrine Carcinoma Avastin Bevacizumab RAD001 Everolimus |
Everolimus Carcinoma, Neuroendocrine Immunologic Factors Bevacizumab Immunosuppressive Agents Angiogenesis Inhibitors Carcinoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Everolimus Neoplasms by Histologic Type Immunologic Factors Carcinoma, Neuroendocrine Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Growth Inhibitors Angiogenesis Modulating Agents Adenocarcinoma Neoplasms, Glandular and Epithelial |