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| Sponsored by: |
University of Iowa |
|---|---|
| Information provided by: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00584012 |
Purpose
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) |
Docetaxel (60 mg/m2) will be given on day 0 every three weeks in Phase I with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this phase I/II study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used.
Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.
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.
Eligibility| Ages Eligible for Study: | 19 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
Contacts and Locations
More Information
| Responsible Party: | University of Iowa ( Susan Roman, DO ) |
| Study ID Numbers: | 200311038 |
| Study First Received: | December 21, 2007 |
| Last Updated: | June 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00584012 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Any cancer Breast cancer Lovastatin Docetaxel |
|
Antimetabolites Docetaxel Skin Diseases Antilipemic Agents Breast Neoplasms |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Lovastatin Breast Diseases |
|
Antimetabolites Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antilipemic Agents Breast Neoplasms Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases Lovastatin |