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

NCT00565227 | Terminated Phase 1 DMC

• 1 other identifier: UMCC 2006.026
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Carcinoma; Prostate Cancer; Bladder Cancer; Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  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%.

Secondary Outcomes (2)

• Although response is not the primary endpoint of this trial, patients with measurable disease will be assessed by standard criteria.

  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.

  All blood levels of the drugs will be conducted during the first cycle of chemotherapy only.

Study Arms (1)

docetaxel plus vorinostat

EXPERIMENTAL

Drug: vorinostat (suberoylanilide hydroxamic acid); Drug: docetaxel

Interventions

vorinostat (suberoylanilide hydroxamic acid) DRUG

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).

Also known as: Zolinza,NSC 701852

docetaxel plus vorinostat

docetaxel DRUG

Docetaxel will be administered as an intravenous infusion (through the vein) on day 4 of each 21-day cycle.

Also known as: Taxotere

docetaxel plus vorinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 3 weeks.
• 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)
• Significant cardiovascular disease including congestive heart failure

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Interventions

Vorinostat; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Deborah Bradley, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: September 1, 2009
• Last Updated: December 2, 2016

Record last verified: 2016-12

Locations

US (1)