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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00337077 |
RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: eribulin mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 129 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy vs prior taxane only vs 2 prior cytotoxic chemotherapy regimens).
Patients receive E7389 IV over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive (i.e., new lesions on bone scan or new/enlarging lesions on CT scan) or stable metastatic disease*
Patients with stable metastases must have a rising PSA level within the past 4 weeks
Meets 1 of the following criteria:
Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure
PATIENT CHARACTERISTICS:
No evidence of ventricular dysrhythmias or other unstable arrhythmia
PRIOR CONCURRENT THERAPY:
No more than 2 prior chemotherapy regimens for hormone-refractory disease
At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression
No concurrent therapeutic anticoagulation with warfarin
Study Chair: | Mark Stein, MD | Cancer Institute of New Jersey |
Investigator: | Gary R. Hudes, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000482413, ECOG-E5805 |
Study First Received: | June 13, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00337077 |
Health Authority: | Unspecified |
recurrent prostate cancer stage IV prostate cancer adenocarcinoma of the prostate |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site |