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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00293371 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving vatalanib together with docetaxel and prednisone may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vatalanib when given together with docetaxel and prednisone and to see how well they work in treating patients with advanced prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: docetaxel Drug: prednisone Drug: vatalanib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of Docetaxel/Prednisone and PTK 787/ZK 222584 in Previously Untreated Metastatic Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 93 |
Study Start Date: | December 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I open-label, dose-escalation study of vatalanib* followed by a phase II study.
NOTE: *Vatalanib is administered on days 5-21 during the first course only.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 93 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, systemic (metastatic) disease despite castrate levels of testosterone due to orchiectomy or luteinizing-hormone releasing hormone (LHRH) agonist, meeting 1 of the following criteria:
Nonmeasurable disease with PSA ≥ 5 ng/mL
Castrate levels of testosterone (< 50 ng/dL) must be maintained
Patients receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression after discontinuation of antiandrogen
Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression
PATIENT CHARACTERISTICS:
No serious uncontrolled, concurrent medical illness, including ongoing or active infection
No "currently active" second malignancy other than nonmelanoma skin cancers
PRIOR CONCURRENT THERAPY:
Patients receiving bisphosphonate therapy prior to initiating protocol treatment must have received bisphosphonates for at least the past month
No concurrent therapeutic warfarin or similar oral anticoagulant that is metabolized by the cytochrome p450 system
No other concurrent hormonal therapy except for the following:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 |
Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000456195, UCSF-04557 |
Study First Received: | February 16, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00293371 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence Vatalanib |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Glucocorticoids Hormones Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |