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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Genentech |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00609765 |
Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy will continue until disease progression or withdrawal due to toxicity.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: Avastin, Fluorouracil, Doxorubicin, Streptozocin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors |
Estimated Enrollment: | 45 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Prospective, single arm, Phase II
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Drug: Avastin, Fluorouracil, Doxorubicin, Streptozocin
PROTOCOL SPECIFIED CHEMOTHERAPY Every 28 Days:
Premedications:
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Patients will need to come for 24 study visits in all. Most study visits will take about 2 hours. At some of these study visits, the doctor
At patient's last visit, they will have a CT scan or MRI.
After treatment starts, patient will:
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Proteinuria at screening as demonstrated by either
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Larry Kvols, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Principal Investigator: | Jonathan Strosberg, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Larry Kvols, M.D. ) |
Study ID Numbers: | MCC-14961, AVF3915s, USFIRB#105337d |
Study First Received: | January 24, 2008 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00609765 History of Changes |
Health Authority: | United States: Institutional Review Board |
advanced unresectable metastatic endocrine tumors |
Antimetabolites Dexamethasone Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Adenoma, Islet Cell Bevacizumab Streptozocin Angiogenesis Inhibitors Immunosuppressive Agents |
Doxorubicin Anti-Bacterial Agents Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenoma Dexamethasone acetate Endocrine Gland Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Bevacizumab Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms Neoplasms by Histologic Type |
Digestive System Neoplasms Growth Substances Endocrine System Diseases Adenoma, Islet Cell Streptozocin Angiogenesis Inhibitors Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Pancreatic Diseases Adenoma Neoplasms, Glandular and Epithelial |