Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Bayer |
---|---|
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00714948 |
Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body. Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug combination used to treat locally advanced and metastatic urothelial cancer. However, these drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer.
New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Sorafenib is an example of a drug that works in this way.
In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the progression of their disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your cancer.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Urinary Bladder |
Drug: gemcitabine and cisplatin plus sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Gemcitabine and Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma |
Estimated Enrollment: | 39 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
This is a phase II trial of gemcitabine and cisplatin plus sorafenib.
|
Drug: gemcitabine and cisplatin plus sorafenib
Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 70 mg/m 2 will be administered on day 1. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have measurable or evaluable urothelial cancer.
Adequate hepatic function defined as:
Exclusion Criteria:
Contact: Matthew Milowsky, MD | milowskm@mskcc.org | |
Contact: Dean Bajorin, MD | bajorind@mskcc.org |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Matthew Milowsky, MD milowskm@mskcc.org | |
Contact: Dean Bajorin, MD bajorind@mskcc.org | |
Principal Investigator: Mattthew Milowsky, MD |
Principal Investigator: | Matthew Milowsky, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Matthew Milowsky, MD ) |
Study ID Numbers: | 07-168 |
Study First Received: | July 10, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00714948 |
Health Authority: | United States: Institutional Review Board |
Bladder Urinary SORAFENIB CISPLATIN GEMCITABINE |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma Carcinoma |
Cisplatin Urologic Diseases Gemcitabine Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial Bladder neoplasm |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |