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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00337077 |
Purpose
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: | Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| 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
Contacts and Locations
Show 155 Study Locations| Study Chair: | Mark Stein, MD | Cancer Institute of New Jersey |
| Investigator: | Gary R. Hudes, MD | Fox Chase Cancer Center |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00337077 History of Changes |
| Other Study ID Numbers: | CDR0000482413, ECOG-E5805 |
| Study First Received: | June 13, 2006 |
| Last Updated: | August 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent prostate cancer stage IV prostate cancer adenocarcinoma of the prostate |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |