Efficacy and Safety Study of Xyotax to Treat Prostate Cancer

Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Paclitaxel polyglumex (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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine -Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; Open label use of Xyotax	Drug: Paclitaxel polyglumex (Xyotax); biologically enhanced chemotherapeutic; Other Names: Xyotax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA response	data from study not available	during trial (data from study not available)
Correlation with soft tissue response	data from study not available	during trial (data from study not available)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression	data from study not available	during trial (data from study not available)

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Collaborators: Cellular Therapeutics
• Investigators: Principal Investigator: Robert J Amato, DO, Baylor College of Medicine - Methodist Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: March 12, 2007
• First Submitted That Met QC Criteria: March 12, 2007
• First Posted (Estimate): March 13, 2007

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Hormone refractory prostate cancer; Adenocarcinoma of the prostate; Recurrent prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Paclitaxel poliglumex
• Other Study ID Numbers: PAC IRB#03-0192-05; PCa-X-02 (Other Identifier: Principal Investigator)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO