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| Sponsor: | US Oncology Research |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | US Oncology Research |
| ClinicalTrials.gov Identifier: | NCT00821327 |
Purpose
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 |
|---|---|---|
|
Urothelial Cancer |
Drug: Gemcitabine, Cisplatin, Suntinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Study Arm
gemcitabine cisplatin sunitinib
|
Drug: Gemcitabine, Cisplatin, Suntinib
Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle. 2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy. 3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Is unable to comply with requirements of study
Contacts and Locations
Show 48 Study Locations| Principal Investigator: | Guru Sonpavde, MD | US Oncology |
| Principal Investigator: | Thomas E Hutson, DO | US Oncology |
More Information
| Responsible Party: | Guru Spondave, MD and Thomas Hutson, DO (Principal and Associate Investigators), US Oncology |
| ClinicalTrials.gov Identifier: | NCT00821327 History of Changes |
| Other Study ID Numbers: | 06040 |
| Study First Received: | January 9, 2009 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Gemcitabine Sunitinib Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |