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Sponsors and Collaborators: |
US Oncology Research Pfizer |
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Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00821327 |
The primary objective of this nonrandomized Phase II study is to evaluate the objective response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the combination of gemcitabine, cisplatin, and sunitinib.
Condition | Intervention | Phase |
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Urothelial Cancer |
Drug: Gemcitabine, Cisplatin, Suntinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma |
Estimated Enrollment: | 43 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Study Arm: Experimental
gemcitabine cisplatin sunitinib
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Drug: Gemcitabine, Cisplatin, Suntinib
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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:
Contact: Mary A Rauch | 832-348-5947 | mary.rauch@usoncology.com |
Principal Investigator: | Matthew D Galsky, MD | US Oncology |
Principal Investigator: | Guru Spondave, MD | US Oncology |
Responsible Party: | US Oncology ( Matthew David Galsky, MD & Guru Spondave, MD ) |
Study ID Numbers: | 06040 |
Study First Received: | January 9, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00821327 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Immunologic Factors Radiation-Sensitizing Agents Cisplatin Sunitinib Gemcitabine |
Carcinoma, Transitional Cell Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Transitional Cell Carcinoma Carcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Cisplatin Radiation-Sensitizing Agents Sunitinib Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Gemcitabine |