Efficacy and Safety Study of Xyotax to Treat Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Cellular Therapeutics
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00446836
First received: March 12, 2007
Last updated: March 15, 2016
Last verified: March 2016
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • PSA response [ Time Frame: during trial (data from study not available) ] [ Designated as safety issue: No ]
    data from study not available

  • Correlation with soft tissue response [ Time Frame: during trial (data from study not available) ] [ Designated as safety issue: No ]
    data from study not available


Secondary Outcome Measures:
  • Time to progression [ Time Frame: during trial (data from study not available) ] [ Designated as safety issue: No ]
    data from study not available


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)
Arms Assigned Interventions
Single arm
Open label use of Xyotax
Drug: Paclitaxel polyglumex (Xyotax)
biologically enhanced chemotherapeutic
Other Name: Xyotax

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00446836     History of Changes
Other Study ID Numbers: PAC IRB#03-0192-05  PCa-X-02 
Study First Received: March 12, 2007
Last Updated: March 15, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2016