Efficacy and Safety Study of Xyotax to Treat Prostate Cancer

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00446836

Collaborator

Cellular Therapeutics (Other)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

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 :

Mar 1, 2005

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Single arm

Open label use of Xyotax

Drug: Paclitaxel polyglumex (Xyotax)

biologically enhanced chemotherapeutic

Other Names:

Xyotax

Outcome Measures

Primary Outcome Measures

PSA response [during trial (data from study not available)]
data from study not available
Correlation with soft tissue response [during trial (data from study not available)]
data from study not available

Secondary Outcome Measures

Time to progression [during trial (data from study not available)]
data from study not available

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)