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| Sponsor: | Hoosier Oncology Group |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by (Responsible Party): | Hoosier Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00706641 |
Purpose
This pilot study is designed to determine feasibility and safety of treatment with dasatinib administered orally once daily for 4 weeks duration prior to radical cystectomy for urothelial carcinoma of the bladder.
| Condition | Intervention |
|---|---|
|
Transitional Cell Carcinoma of the Bladder |
Drug: Dasatinib Procedure: Radical Cystectomy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Neoadjuvant Dasatinib Followed by Radical Cystectomy for Transitional Cell Carcinoma of the Bladder |
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Dasatinib
Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Procedure: Radical Cystectomy
Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
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OUTLINE: This is a multi-center study.
This is a pilot study designed to determine the safety and feasibility of treatment with dasatinib 100 mg administered orally once daily for 4 weeks duration prior to radical cystectomy for patients with muscle-invasive transitional cell carcinoma of the bladder ineligible for and/or willing to forgo neoadjuvant cisplatin-based combination chemotherapy. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
ECOG Performance Status 0-1
Life Expectancy: Not specified
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
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: Noah Hahn, M.D. | 317-278-6942 | nhahn@iupui.edu |
| Contact: Cynthia Burkhardt, R.N. | 317-921-2050 | cyburkha@iupui.edu |
| United States, Indiana | |
| Indiana University Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Noah Hahn, M.D. 317-278-6942 nhahn@iupui.edu | |
| Contact: Kerry Bridges 317-274-2552 kdbridge@iupui.edu | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Seth Lerner, M.D. 713-798-6841 | |
| United States, Virginia | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Mark Fleming, M.D. 757-213-5813 mark.fleming@usoncology.com | |
| Contact: Wendi Gobhart 757.213.5813 wendi.gobhart@usoncology.com | |
| Study Chair: | Noah Hahn, M.D. | Hoosier Oncology Group, Inc. |
More Information
| Responsible Party: | Hoosier Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00706641 History of Changes |
| Other Study ID Numbers: | GU07-122 |
| Study First Received: | June 25, 2008 |
| Last Updated: | August 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Urinary Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases |
Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |