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Phase I study of ixabepilone, mitoxantrone, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy: a study of the Department of Defense Prostate Cancer Clinical Trials Consortium
Journal of Clinical Oncology, 06/17/09

Rosenberg JE et al. - In a study to assess the use of mitoxantrone plus prednisone and ixabepilone as second-line chemotherapy in docetaxel-refractory castration-resistant prostate cancer (CRPC) pts, results suggest that the combination of ixabepilone and mitoxantrone is feasible and active in CRPC and requires dosing with pegfilgrastim.

Methods

Metastatic CRPC pts progressing during or after taxane-based chemotherapy enrolled in a study of ixabepilone and mitoxantrone administered every 21 days along with prednisone.
Ixabepilone and mitoxantrone doses were alternately escalated in a standard 3 + 3 design.
Pts were evaluated for toxicity and disease response.
Dose-limiting toxicities (DLTs) were defined as treatment related, occurring during cycle 1, and included grade 4 prolonged or febrile neutropenia, thrombocytopenia (grade 4 or grade 3 with bleeding), or grade 3 nonhematologic toxicity.

Results

36 pts were treated; 59% of pts experienced grade 3/4 neutropenia.
DLTs included grade 3 diarrhea (n=1), prolonged grade 4 neutropenia (n=4), and grade 5 neutropenic infection (n=1).
Due to prolonged neutropenia, the highest dose levels were repeated with pegfilgrastim on day 2 of each cycle.
Maximum tolerated dose in combination with pegfilgrastim was not exceeded.
Recommended phase II dose is mitoxantrone 12 mg/m2 and ixabepilone 35 mg/m2 every 21 days, pegfilgrastim 6 mg subcutaneously day 2, and continuous prednisone 5 mg twice per day.
31% of pts have experienced ≥50% prostate-specific antigen (PSA) declines, and 2 experienced objective responses.
Of 21 pts treated with mitoxantrone 12 mg/m2 plus ixabepilone ≥30 mg/m2, 9 (43%) experienced ≥50% PSA declines.

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