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Sponsored by: |
University of Iowa |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00584012 |
This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin. There are two phases. Subjects in Phase I can have any cancer. This phase will determine the highest dose of lovastatin and docetaxel that can be given safely as well as the safety of combining the two drugs and the effect on the subject's tumor. Phase II will administer lovastatin and docetaxel only to subjects who have breast cancer tumors.
Condition | Intervention | Phase |
---|---|---|
Any Cancer Breast Cancer |
Drug: Lovastatin and Docetaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer |
Estimated Enrollment: | 96 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
The primary objective of this study is to determine the maximum tolerated dose (MTD) of lovastatin and docetaxel in patients with various different cancers (phase I). Once the MTD for this drug combination has been determined, patients with breast cancer will be entered into a single cohort, the phase II portion of this study, and treated with the MTD doses of both lovastatin and docetaxel.
Ages Eligible for Study: | 19 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan Roman, DO | 319-384-9497 | susan-roman@uiowa.edu |
Contact: Mary Shannon, RN | 319-356-3516 | mary-shannon@uiowa.edu |
United States, Iowa | |
Holden Comprehensive Cancer Center | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Susan Roman, DO 319-384-9497 susan-roman@uiowa.edu | |
Contact: Mary Shannon, RN 319-356-3516 | |
Principal Investigator: Susan Roman, DO |
Principal Investigator: | Susan Roman, DO | University of Iowa |
Responsible Party: | University of Iowa ( Susan Roman, DO ) |
Study ID Numbers: | 200311038 |
Study First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00584012 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Any cancer Breast cancer Lovastatin Docetaxel |
Docetaxel Skin Diseases Breast Neoplasms Lovastatin Breast Diseases |
Antimetabolites Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |