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A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat) (NSC 701852) in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies

Phase 1
18 Years
Not Enrolling
Non-small Cell Lung, Prostate, Bladder/Urothelial Cancers.

Thank you

Trial Information

A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat) (NSC 701852) in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies

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 [Taxotereâ„¢]) 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.

Inclusion Criteria:

1. There is no limit on prior courses of chemotherapy as long as the regimen did not
contain docetaxel. Prior use of paclitaxel (Taxol) or other taxanes is permissible.

2. Only patients with non-small cell lung, prostate, and bladder/urothelial cancer that
has progressed after chemotherapy or after hormone therapy.

Exclusion Criteria:

1. Patients who have had chemotherapy or radiotherapy within 3 weeks.

2. Patients may not be receiving any other investigational agents nor had prior
treatment with histone deacetylase (HDAC) inhibitors (i.e. Valproic acid, PXD-001,
Depsipeptide, MS-275 and LAQ-824)

3. Significant cardiovascular disease including congestive heart failure

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The TITE-CRM dose escalation scheme will be used in this study to determine the maximum tolerated dose (MTD) of the combination therapy.

Outcome 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%.

Safety Issue:


Principal Investigator

Deborah Bradley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2006.026



Start Date:

April 2007

Completion Date:

September 2009

Related Keywords:

  • Non-small Cell Lung, Prostate, Bladder/Urothelial Cancers.



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752