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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Beth Israel Deaconess Medical Center Brigham and Women's Hospital Amgen |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00808639 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Toni Choueiri, MD | 617-632-4524 | |
| Contact: Angela Qu | 617-632-2165 |
| 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 | |
| Lahey Clinic | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Nevin Bhardwaj 781-744-8400 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Shelley Cameron, RN, OCN 412-623-4868 cameronsj2@upmc.edu | |
| Contact: Diana Long, RN 412-647-8475 smitml2@upmc.edu | |
| Principal Investigator: | Toni Choueiri, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Toni Choueiri, MD, Dana-Farber Cancer Instiutte |
| ClinicalTrials.gov Identifier: | NCT00808639 History of Changes |
| Other Study ID Numbers: | 08-208 |
| Study First Received: | December 15, 2008 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
pegfilgrastim MVAC |
|
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Cisplatin Doxorubicin Methotrexate Vinblastine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic |
Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Phytogenic Tubulin Modulators |