Overview

Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies.

Status:
Terminated

Trial end date:
2009-09-01

Target enrollment:
0

Participant gender:
All

Summary

Vorinostat (Suberoylanilide Hydroxamic Acid; NSC 701852) is a drug that inhibits an enzyme that plays a key role in the regulation of cell survival, growth, and eventual cell death, all of which play a role in cancer. As a result, this drug has the potential to affect a tumor's ability to survive. Vorinostat is the most potent drug of its kind that is currently under investigation in clinical trials. The primary objective of this study is to define the maximum safest dose of vorinostat in combination with a standard chemotherapy agent, docetaxel, in patients with advanced and relapsed lung, bladder, or prostate cancer.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Michigan Cancer Center
University of Michigan Rogel Cancer Center

Treatments:

Docetaxel
Vorinostat

Criteria

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