EPO906 Therapy in Patients With Prostate Cancer

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00035113

Collaborator

(none)

Enrollment

Locations

Duration (Months)

9.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: epothilone b	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2004

Outcome Measures

Primary Outcome Measures

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) []

Secondary Outcome Measures

Time to progression []
Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

The following patients may be eligible for this study:

Patients with any histologically proven prostate cancer with measurable metastatic disease or PSA progression > 20ng/ml after initial hormonal therapy will be eligible
Patients must be maintained on androgen ablation therapy with a LHRH agonist or have undergone orchiectomy
Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents
Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks
For patients with disease progression defined solely by PSA increase: two consecutive rises in PSA measurement, over a 4-week period (each separated from the previous by 2 weeks) - the last measurement must be at least 50% greater than the nadir PSA achieved after the last therapeutic maneuver
For patients who discontinued bicalutamide therapy prior to study entry, a third rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over a 6 week period)
Must have a life expectancy of greater than three (3) months
Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal if transaminases are less than or equal to the upper limit of normal
For patients with disease progression defined by measurable disease: changes in measurable size of lymph nodes or parenchymal masses on physical or radiologic examination (bone scan findings are not adequate to assess measurable disease).

Exclusion Criteria:

The following patients are not eligible for the study:

Patients with symptomatic CNS metastases or leptomeningeal involvement
Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
Patients with severe cardiac insufficiency
Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
Patients who received palliative radiotherapy to tumors located centrally less than 4 weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated peripheral bone metastases is allowed)
Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of anti-androgen therapy (42 days for bicalutamide)
Patients who have had more than one prior chemotherapy regimen for hormone-resistant metastatic disease
Patients with disease measurable only by bone scan
Patients who have received corticosteroids within the past 28 days (may be waived with approval from Novartis)
History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer
Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
Patients with radiation therapy or chemotherapy within the last four weeks
Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
HIV+ patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Shores Medical Group	Long Beach	California	United States	90813
2	California Pacific Medical Center	San Francisco	California	United States	94115
3	University of Maryland - Greenbaum Cancer Center	Baltimore	Maryland	United States	21201
4	Cancer Institute of New Jersey (CINJ)	New Brunswick	New Jersey	United States	08901
5	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109