Efficacy and Safety Study of Xyotax to Treat Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446836
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : March 17, 2016
Cellular Therapeutics
Information provided by (Responsible Party):
The Methodist Hospital System

Brief Summary:
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 or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Paclitaxel polyglumex (Xyotax) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer
Study Start Date : March 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Single arm
Open label use of Xyotax
Drug: Paclitaxel polyglumex (Xyotax)
biologically enhanced chemotherapeutic
Other Name: Xyotax

Primary Outcome Measures :
  1. PSA response [ Time Frame: during trial (data from study not available) ]
    data from study not available

  2. Correlation with soft tissue response [ Time Frame: during trial (data from study not available) ]
    data from study not available

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: during trial (data from study not available) ]
    data from study not available

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446836

United States, Texas
Baylor College of Medicine -Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Cellular Therapeutics
Principal Investigator: Robert J Amato, DO Baylor College of Medicine - Methodist Hospital

Responsible Party: The Methodist Hospital System Identifier: NCT00446836     History of Changes
Other Study ID Numbers: PAC IRB#03-0192-05
PCa-X-02 ( Other Identifier: Principal Investigator )
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Methodist Hospital System:
Adenocarcinoma of the prostate
Recurrent prostate cancer
Hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases