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Sponsors and Collaborators: |
University of Michigan Abraxis BioScience Inc. |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00585689 |
Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.
Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells.
ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies.
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: ABI-007, Carboplatin, Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder |
Estimated Enrollment: | 54 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | August 2011 (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: Cancer AnswerLine | 1-800-865-1125 |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Principal Investigator: David C Smith, MD | |
Sub-Investigator: Maha Hussain, MD | |
Sub-Investigator: Kathleen Cooney, MD | |
Sub-Investigator: Deborah Bradley, MD |
Principal Investigator: | David C Smith, MD | University of Michigan |
Responsible Party: | University of Michigan ( David C, Smith, M.D. ) |
Study ID Numbers: | UMCC 2007.061 |
Study First Received: | December 26, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00585689 |
Health Authority: | United States: Institutional Review Board |
Locally advanced urothelial carcinoma of the bladder |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carboplatin Carcinoma, Transitional Cell Urologic Neoplasms |
Transitional cell carcinoma Carcinoma Urologic Diseases Paclitaxel Gemcitabine Urinary tract neoplasm Bladder neoplasm |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |