Adenocarcinoma of the Prostate Clinical Trial
Official title:
A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer
This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer
PRIMARY OBJECTIVES:
I. Determine the efficacy of ixabepilone (BMS-247550) vs mitoxantrone and prednisone, in
terms of decline in prostate-specific antigen (PSA) levels, in patients with
taxane-resistant, hormone-refractory metastatic prostate cancer.
SECONDARY OBJECTIVES:
I. Determine the safety of these regimens in these patients. II. Determine the objective
response rate in patients with measurable disease who are treated with these regimens.
III. Determine the clinical activity of each of these regimens after crossover in patients
who experience disease progression on their originally assigned treatment arm and switch to
the other treatment arm.
OUTLINE: This is a randomized, crossover, multicenter study. Patients are stratified
according to ECOG performance status (0 vs 1 or 2). Patients are randomized to 1 of 2
treatment arms.
ARM I: Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.
ARM II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice
daily on days 1-21.In both arms, courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
Patients who progress while on treatment after at least 2 courses or discontinue treatment
for any other reason may cross over to the other arm and receive treatment as above,
beginning within 12 weeks of last study treatment on original arm.
Patients are followed every 3 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02217709 -
Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer
|
Phase 2 | |
| Completed |
NCT03077659 -
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03624660 -
Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer
|
N/A | |
| Completed |
NCT01054079 -
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
|
Phase 2 | |
| Terminated |
NCT00512668 -
Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer
|
Phase 1 | |
| Completed |
NCT00087139 -
Ixabepilone in Treating Patients With Metastatic Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00182052 -
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03511196 -
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
|
Early Phase 1 | |
| Active, not recruiting |
NCT01655836 -
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
|
Phase 1 | |
| Terminated |
NCT03535675 -
Muscadine Plus (MPX) In Men With Prostate Cancer
|
Phase 3 | |
| Terminated |
NCT01866423 -
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 2 | |
| Completed |
NCT02234921 -
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
|
Phase 1 | |
| Completed |
NCT01468532 -
Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03686683 -
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03689699 -
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04694924 -
Prospective Prostate Cancer and Patient-reported Outcomes Registry
|
||
| Active, not recruiting |
NCT04909294 -
Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma
|
N/A | |
| Completed |
NCT02225925 -
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
|
N/A | |
| Completed |
NCT01949519 -
Docetaxel and Lycopene in Metastatic Prostate Cancer
|
Phase 1 | |
| Completed |
NCT01433913 -
Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
|
Phase 2 |