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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: | NCT00087139 |
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: ixabepilone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 83 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
To determine the effect on percent with a 50% decrease in PSA response in patients with metastatic prostate cancer who have progressed on androgen ablation therapy and are classified into 1 of 3 separate categories:
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).
Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 83 patients (27 for the no prior chemotherapy stratum; 27 each for the 2 prior cytotoxic chemotherapy regimens and prior docetaxel strata) will be accrued for this study within 8-22 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Evidence of disease progression (e.g., new lesions on bone scan or new/enlarging lesions on CT scan) OR rising prostate-specific antigen (PSA) within the past 4 weeks
Patients with stable disease and rising PSA must show 2 consecutive rises in PSA measurements taken at least 2 weeks apart
Failed prior bilateral orchiectomy or other primary hormonal therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No evidence of ventricular dysrhythmias or other unstable arrhythmia
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic warfarin
Study Chair: | Glenn Liu, MD | University of Wisconsin, Madison |
Investigator: | Robert S. DiPaola, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000372946, ECOG-E3803 |
Study First Received: | July 8, 2004 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00087139 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Epothilones Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Pharmacologic Actions |