Trial | NCT00446836  Report issue

Title

Efficacy and Safety Study of Xyotax to Treat Prostate Cancer
Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    paclitaxel ...

  • Study Participants

    29
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.
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 Started
Mar 31
2005
Primary Completion
Nov 30
2007
Study Completion
Jan 31
2008
Last Update
Mar 17
2016
Estimate

Drug Paclitaxel polyglumex (Xyotax)

biologically enhanced chemotherapeutic

  • Other names: Xyotax

Single arm Other

Open label use of Xyotax

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)
No Results Posted