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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Massachusetts General Hospital AstraZeneca |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00880334 |
In this research study the investigators are looking to see if the combination of docetaxel plus Zactima is effective in the treatment of metastatic transitional cell carcinoma (TCC). Docetaxel is a chemotherapy drug that kills cancer cells that are dividing. It is widely used in TCC. Zactima is a drug that is believed to stop new blood vessels from forming around cancer cells. The combination of docetaxel and Zactima has been studied in people with lung cancer and found to be helpful in killing cancer cells. Thus, this study is looking at people with TCC, to see if the combination of docetaxel plus Zactima is better or worse then docetaxel alone.
Condition | Intervention | Phase |
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Transitional Cell Carcinoma Urothelial Cancer |
Drug: Docetaxel Drug: Zactima Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Randomized Study of Docetaxel +/- ZD6474 in Metastatic TCC |
Estimated Enrollment: | 140 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Zactima & Docetaxel: Experimental
Zactima orally and Docetaxel intravenously
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Drug: Docetaxel
Given intravenously on Day 1 of each 21-day cycle
Drug: Zactima
taken orally once a day, every day
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Placebo and Docetaxel: Active Comparator
Placebo orally and docetaxel intravenously
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Drug: Docetaxel
Given intravenously on Day 1 of each 21-day cycle
Drug: Placebo
Taken orally once a day every day
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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: Toni Choueiri, MD | 617-632-4524 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Toni Choueiri, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Glenn Bubley, MD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Dror Michaelson, MD |
Principal Investigator: | Toni Choueiri, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Toni Choueiri, MD ) |
Study ID Numbers: | 06-116 |
Study First Received: | April 10, 2009 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00880334 History of Changes |
Health Authority: | United States: Food and Drug Administration |
TCC Zactima docetaxel ZD6474 taxotere |
Docetaxel Carcinoma, Transitional Cell Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Docetaxel Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Carcinoma, Transitional Cell Pharmacologic Actions Neoplasms, Glandular and Epithelial Carcinoma |