EPO906 Therapy in Patients With Prostate Cancer

NCT00035113 | Completed Phase 2

• 1 other identifier: CEPO906A2204
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostatic Neoplasms

Keywords

prostate cancer; prostate; androgen independent; cancer; tumor; tumour; neoplasm; carcinoma; intravenous; epothilone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Time to progression

• Overall survival

Interventions

epothilone b DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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• Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Maryland - Greenbaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Cancer Institute of New Jersey (CINJ)

New Brunswick, New Jersey, 08901, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Carcinoma

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: January 1, 2002
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (5)