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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00471718 |
RATIONALE: Drugs used in chemotherapy, such as ABT-751, 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 I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: ABT-751 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase1/2 Trial of ABT-751 in Patients With Advanced, Androgen-Independent Prostate Cancer |
Estimated Enrollment: | 53 |
Study Start Date: | October 2004 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 50 additional patients may be treated at the recommended phase II dose (RPTD) which is the dose level at the maximally administered dose.
PROJECTED ACCRUAL: A total of 53 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:
Histologically confirmed adenocarcinoma of the prostate
Metastatic disease (e.g., bone, pelvic mass, nodal, liver, or lung metastases) with evidence of disease progression by radiography (including bone scans observed during last treatment) or serology
Underwent prior bilateral orchiectomy or other primary hormonal therapy (e.g., luteinizing hormone-releasing hormone [LHRH] therapy or estrogen) with subsequent evidence of treatment failure and simultaneous documentation of a castrate testosterone level ≤ 50 ng/dL
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 3 weeks since prior radiotherapy
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 |
Study Chair: | Bruce J. Roth, MD | Vanderbilt-Ingram Cancer Center |
Responsible Party: | Vanderbilt-Ingram Cancer Center ( Bruce J. Roth ) |
Study ID Numbers: | CDR0000543847, VU-VICC-URO-0426 |
Study First Received: | May 8, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00471718 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site |