Study of KOS-862 (Epothilone D) in Metastatic Prostate Cancer

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00104130
• Collaborator: (none)
• Enrollment: 53
• Locations: 9
• Duration (Months): 2
• Patients Per Site: 5.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The purpose of this trial is to study KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: KOS-862	Phase 2

Detailed Description

This study is a Phase 2, single arm study of KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen. PSA response is the primary end-point and objective responses will be checked as available.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of KOS-862 Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Hormone Resistant Prostate Cancer Who Have Progressed Following Initial Therapy for Metastatic Disease
• Study Start Date: Dec 1, 2004
• Study Completion Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

1. prostate cancer []

2. prostate-specific antigen (PSA) response []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years of age.

• Metastatic disease.

• One previous treatment including docetaxel (Taxotere).

• At least 3 weeks since last surgery/radiation/chemotherapy

• ECOG Performance Status of 0, 1 or 2

Exclusion Criteria:

• Active brain metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Medical Center	Vallejo	California	United States	94589
2	Georgia Cancer Specialists	Tucker	Georgia	United States	30084
3	University of Maryland Medical System	Baltimore	Maryland	United States	21201
4	Washington University School of Medicine	St. Louis	Missouri	United States	63310
5	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
6	Kaiser Permanente NW Oncology Clinic	Portland	Oregon	United States	97227
7	Oregon Health & Science University	Portland	Oregon	United States	97239
8	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
9	University of Washington	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00104130
• Other Study ID Numbers: KOS-202/NO18401
• First Posted: Feb 24, 2005
• Last Update Posted: Sep 17, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: prostate
• Additional relevant MeSH terms: Prostatic Neoplasms; Desoxyepothilone B

Study Results

No Results Posted as of Sep 17, 2008