Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital Amgen |
---|---|
Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00808639 |
The purpose of this research study is to test the effectiveness of neoadjuvant chemotherapy in combination with pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial carcinoma.
Condition | Intervention | Phase |
---|---|---|
Urothelial Cancer Muscle-Invasive Urothelial Carcinoma |
Drug: Methotrexate Drug: Doxorubicin Drug: vinblastine Drug: cisplatin Drug: Pegfilgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Neoadjuvant Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma |
Estimated Enrollment: | 39 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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 | |
Contact: Gina Scibelli | 617-632-5598 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Toni Choueiri, MD | |
Beth Israel Deaconess Medical Center | Not yet recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Glenn Bubley, MD |
Principal Investigator: | Toni Choueiri, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Instiutte ( Toni Choueiri, MD ) |
Study ID Numbers: | 08-208 |
Study First Received: | December 15, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00808639 |
Health Authority: | United States: Institutional Review Board |
pegfilgrastim MVAC |
Folic Acid Cisplatin Mannitol Methotrexate Vinblastine |
Carcinoma, Transitional Cell Transitional cell carcinoma Doxorubicin Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Reproductive Control Agents Folic Acid Antagonists |
Antibiotics, Antineoplastic Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Abortifacient Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic Dermatologic Agents Nucleic Acid Synthesis Inhibitors |