Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies.
|Non-Small-Cell Lung Carcinoma Prostate Cancer Bladder Cancer Urothelial Carcinoma||Drug: vorinostat (suberoylanilide hydroxamic acid) Drug: docetaxel||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat) (NSC 701852) in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies|
- The TITE-CRM dose escalation scheme will be used in this study to determine the maximum tolerated dose (MTD) of the combination therapy. [ Time Frame: After 25 evaluable patients are accrued, a final set of side-effect estimates will be produced for each dose level, and the MTD will be the highest dose with a side-effect estimate at or below the target toxicity estimate of 30%. ]
- Although response is not the primary endpoint of this trial, patients with measurable disease will be assessed by standard criteria. [ Time Frame: For the purposes of this study, tumor response will be assessed every 6 weeks. ]
- To evaluate the blood levels of vorinostat and docetaxel when administered in combination. [ Time Frame: All blood levels of the drugs will be conducted during the first cycle of chemotherapy only. ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
|Experimental: docetaxel plus vorinostat||
Drug: vorinostat (suberoylanilide hydroxamic acid)
Vorinostat will be administered by mouth as a pill for the first 14 days on a continuous basis during of each 21-day cycle (2 weeks of treatment, 1 week break).
Other Name: Zolinza,NSC 701852Drug: docetaxel
Docetaxel will be administered as an intravenous infusion (through the vein) on day 4 of each 21-day cycle.
Other Name: Taxotere
Vorinostat (also known as Suberoylanilide Hydroxamic Acid) is a new investigational drug that is not approved by the Food and Drug Administration. This drug has shown promising activity against a number of cancers. We want to determine if treatment with vorinostat in combination with a standard type of chemotherapy (docetaxel [Taxotere™]) is safe and possibly better than treatment with docetaxel alone. We also want to find out more about how patients and the cancer will react to the drugs, what happens to vorinostat in the human body (how your body reacts to this drug and breaks it down) and about its side effects when used in combination with chemotherapy (docetaxel).
The purpose of this study is to:
- Test the safety of the research study drug, vorinostat
- To determine if any toxicities or severe side effects occur when combining vorinostat with docetaxel (a standard chemotherapy treatment)
- To study how your body takes in, breaks down and responds to vorinostat
- To obtain more evidence of the ability of vorinostat to react against cancer, such as the kind that you have.
The use of vorinostat in combination with chemotherapy such as docetaxel may result in improved response of the cancer to treatment. Indeed, vorinostat may have an added benefit with docetaxel by promoting cancer cell death. This is because both drugs can interfere with the ability of the cancer to grow, although the way vorinostat does this is not clearly defined. Vorinostat and docetaxel both can disrupt the cancer's ability to produce daughter cancer cells and therefore, the administration of vorinostat before docetaxel is hoped to be better then either drug alone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565227
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Deborah Bradley, MD||University of Michigan Cancer Center|