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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00589420 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: docetaxel Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Sorafenib in Combination With Docetaxel in Patients With Androgen-Independent Prostate Cancer |
Estimated Enrollment: | 69 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels before and after therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Disease progression during hormonal therapy, defined by one or more of the following:
PATIENT CHARACTERISTICS:
No serious medical illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior radiotherapy
No concurrent inhibitors of CYP3A, including any of the following:
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 |
Investigator: | Amy Kramer, RN, MPA | University of Pennsylvania |
Responsible Party: | Abramson Cancer Center of the University of Pennsylvania ( Amy Kramer ) |
Study ID Numbers: | CDR0000581020, UPCC-03806, SANOFI-AVENTIS-UPCC-03806 |
Study First Received: | December 25, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00589420 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Sorafenib Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |