| Protocol No. | 11951 | Principal Investigator | Ryan, Charles |
| Phase | I (Cancer Control) |
| Age Group | Adult | Scope | National |
| Secondary Protocol No. | N/A |
| Title | A Phase I Study of Cabazitaxel, Mitoxantrone, and Prednisone (CAMP) for Patients with Metastatic Castration-Resistant Prostate Cancer and no Prior Chemotherapy |
| Objective | Primary Objective: To determine the MTD and dose-limiting toxicities of the combination of cabazitaxel and mitoxantrone/prednisone as chemotherapy for patients with metastatic CRPC who have not received prior chemotherapy for metastatic disease. |
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| Key Eligibility | 1. Histologically confirmed adenocarcinoma of the prostate.
2. Progressive metastatic prostate cancer (positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or LHRH agonist therapy).
3. Patients may have either non-measurable disease OR measurable disease
4. All patients must have a PSA >/= 2 ng/mL.
5. Progressive disease based on any one of the following: transaxial imaging; a rise in PSA; radionuclide bone scan
*Patients whose sole manifestation of progression is an increase in disease-related symptoms are not eligible. |
| Applicable Disease Sites | Prostate |
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| Therapies Involved | Chemotherapy multiple agents systemic |
| Drugs Involved | Cabazitaxel
Immunex (Mitoxantrone)
Jevtana (Cabazitaxel)
Mitoxantrone
Mitoxantrone dihydrochloride (Mitoxantrone)
Mitoxantrone hydrochloride (Mitoxantrone)
Novantron (Mitoxantrone)
Prednisone
XRP6258 (Cabazitaxel) |
| Status | Open |
| Participating Institutions | CTSI CRC Mt. Zion : Ryan Courtin
University of California San Francisco : Ryan Courtin |
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| Eligibility Document | 11951_CTGovEligibility_NCT01594918.doc |
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| Contact | Ryan Courtin |
Phone:415-353-7284
Pager:
Email:CourtinR@cc.ucsf.edu |