Brief Title
Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies.
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
Brief 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.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
The TITE-CRM dose escalation scheme will be used in this study to determine the maximum tolerated dose (MTD) of the combination therapy.
Secondary Outcome
Although response is not the primary endpoint of this trial, patients with measurable disease will be assessed by standard criteria.
Condition
Non-Small-Cell Lung Carcinoma
Intervention
vorinostat (suberoylanilide hydroxamic acid)
Study Arms / Comparison Groups
docetaxel plus vorinostat
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
April 2007
Completion Date
September 2009
Primary Completion Date
November 2008
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Deborah Bradley, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00565227
Organization ID
UMCC 2006.026
Responsible Party
Sponsor
Study Sponsor
University of Michigan Rogel Cancer Center
Study Sponsor
Deborah Bradley, MD, Principal Investigator, University of Michigan Rogel Cancer Center
Verification Date
December 2016