Efficacy and Safety Study of Xyotax to Treat Prostate Cancer - Full Text View

Sponsors and Collaborators:	The Methodist Hospital System Cellular Therapeutics
Information provided by:	The Methodist Hospital System
ClinicalTrials.gov Identifier:	NCT00446836

Purpose

The purpose of this study is to determine whether Xyotax, a conjugate of the taxane drug paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to hormone therapy.

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Paclitaxel polyglumex (Xyotax)	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Paclitaxel Paclitaxel Poliglumex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer

Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:

PSA response
Correlation with soft tissue response

Secondary Outcome Measures:

Time to progression

Enrollment:	29
Study Start Date:	March 2005
Study Completion Date:	January 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Prostate cancer is the second leading cause of cancer death in American men. Hormonal ablation, in the form of medical or surgical castration, is the cornerstone of management for metastatic prostate cancer; however, treatment options for a patient in whom androgen ablation fails are limited. Docetaxel and paclitaxel, taxanes that are cell cycle specific, play a major role in advanced hormone-refractory prostate cancer treatment. In preclinical studies, Xyotax, a conjugate of paclitaxel with enhanced permeability and retention in tumor tissue, has an improved therapeutic profile, with both decreased systemic drug-related toxicities and enhanced efficacy. Xyotax as a single agent has been studied in a broad variety of syngeneic and xenogeneic tumor models. Recognizing that taxanes are active in prostate cancer and preclinical data reports activity with Xyotax in docetaxel and paclitaxel resistant cell lines, there is significant rationale to develop this agent in prostate cancer. Thus, a phase II study is needed to evaluate the antitumor activity in two subsets of hormone refractory prostate cancer patients: those with no prior systemic and those with one prior systemic therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Progressing adenocarcinoma of the prostate having failed prior hormone therapy
Free of serious co-morbidity
Have a life expectancy of ≥ 24 weeks
Maintaining castrate status (either surgically or hormonally)

Exclusion Criteria:

Patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by MRI for at least 6 months
Patients known to be HIV positive
Patients with active autoimmune disease
Patients involving concurrent anticancer drug therapy
Patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable CHF, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446836

Locations

United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030

Sponsors and Collaborators

The Methodist Hospital System

Cellular Therapeutics

Investigators

Principal Investigator:

Robert J Amato, DO

The Methodist Hospital Research Institute

More Information

Responsible Party:	The Methodist Hospital Research Institute ( Robert J. Amato, D.O. )
Study ID Numbers:	PCa-X-02, 03-0192-05
Study First Received:	March 12, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00446836
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:

Adenocarcinoma of the prostate
Recurrent prostate cancer
Hormone refractory prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Paclitaxel
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009