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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00059631 |
Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Mitoxantrone in combination with PS-341 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of Weekly Intravenous PS-341 (Bortezomib) Plus Mitoxantrone in Patients With Advanced Androgen-Independent Prostate Cancer (AI-PCa) |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Previous or concurrent hormone therapy with a luteinizing hormone-releasing hormone analog (e.g., leuprolide) does not preclude enrollment in the study. In fact, patients should continue on LHRH analog therapy throughout the study period, if this is their mode of androgen suppression therapy. Patients should have discontinued anti-androgen therapy for > than 4 weeks (for flutamide) or > 6 weeks (for bicalutamide and nilutamide).
Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray, as per the RECIST CRITERIA- Appendix A).
Patient has all of the following pretreatment laboratory data within 14 days before registration, except for serum testosterone which may be done within 28 days prior to registration.
Exclusion criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
Patients with significant atherosclerotic disease, as defined by:
United States, Texas | |
M.D.Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Arlene Siefker-Radtke, MD | UT M.D. Anderson Cancer Center |
Study ID Numbers: | ID02-227 |
Study First Received: | April 29, 2003 |
Last Updated: | August 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00059631 |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer |
Prostatic Diseases Genital Neoplasms, Male Bortezomib Urogenital Neoplasms |
Mitoxantrone Genital Diseases, Male Prostatic Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors Neoplasms |
Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |