At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate
- ✓Progressive metastatic disease despite castrate testosterone levels (bone scan positive or measurable disease on imaging)
- ✓Prior ≥3 courses of paclitaxel- or docetaxel-based therapy with documented disease progression during or after therapy
- ✓Only 1 prior chemotherapy regimen allowed (re-treatment with same taxane allowed)
- ✕No prior mitoxantrone, ixabepilone, or other epothilones
- ✕No severe Cremophor® EL hypersensitivity
- ✕No pre-existing motor or sensory neuropathy >grade 1
- ✕No uncontrolled serious infections or medical illnesses
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of Epothilone Analog BMS-247550 (Ixabepilone), Mitoxantrone, and Prednisone in Hormone Refractory Prostate Cancer (HRPC) Patients Previously Treated With Chemotherapy
In Brief
A Phase 2 clinical trial evaluating mitoxantrone hydrochloride, ixabepilone, and 1 other intervention for Adenocarcinoma of the Prostate and 2 related conditions. Completed, enrolled 100 participants across 2 sites.
Detailed Summary
This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells
Study Details
Timeline
Interventions
Given IV
Given IV
Given orally