NCT00446836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

March 12, 2007

Last Update Submit

March 15, 2016

Conditions

Prostatic Neoplasms

Keywords

Adenocarcinoma of the prostateRecurrent prostate cancerHormone refractory prostate cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Time to progression

    during trial (data from study not available)

Study Arms (1)

Single arm

OTHER

Open label use of Xyotax

Drug: Paclitaxel polyglumex (Xyotax)

Interventions

Paclitaxel polyglumex (Xyotax)DRUG

biologically enhanced chemotherapeutic

Also known as: Xyotax
Single arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine -Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

paclitaxel poliglumex

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Robert J Amato, DO

    Baylor College of Medicine - Methodist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

March 1, 2005

Primary Completion

November 1, 2007

Study Completion

January 1, 2008

Last Updated

March 17, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)