Prostatic Neoplasms
Conditions
Keywords
Adenocarcinoma of the prostate, Recurrent prostate cancer, Hormone refractory prostate cancer
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.
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.
Interventions
DRUGPaclitaxel polyglumex (Xyotax)
biologically enhanced chemotherapeutic
Sponsors
Cellular Therapeutics
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | during trial (data from study not available) | data from study not available |
Countries
United States
Outcome results
None listed