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- W2253889655 abstract "4623 Background: Estramustine in combination with taxanes has demonstrated synergistic antitumor activity in patients (pts) with hormone-refractory prostate cancer. However, taxanes are associated with hematologic toxicity and the development of drug resistance. EPO906 is a novel epothilone that induces microtubule polymerization and has demonstrated clinical cytotoxic activity in taxane-sensitive, -resistant, and -refractory tumors. Phase I studies show EPO906 has a favorable safety profile compared with docetaxel. Methods: We investigated the MTD of EPO906 plus estramustine in pts with advanced cancer. Pts with stage III/IV solid tumors and a performance status ≤ 2 were eligible. DLT was defined as grade (gr) 4 neutropenia and thrombocytopenia, febrile neutropenia, ≥ gr 3 nonhematologic toxicity, or gr 2 renal toxicity. Pts received weekly oral estramustine 280 mg BID days 1 - 3 and EPO906 starting at 0.5 mg/m2 via 5-min IV infusion weekly on day 2 for 3 wk followed by 1 wk of rest. EPO906 was escalated by 0.5-mg/m2 increments to 2.5 mg/m2 in cohorts of 3 - 6 pts. Results: Thus far, 14 pts have been enrolled. Tumor types are predominantly prostate and breast cancer. All pts except 1 had received prior taxane therapy. Median age was 61 yrs (range, 40 - 75 yrs). Three pts were treated in cohort 1 (0.5 mg/m2), 3 in cohort 2 (1.5 mg/m2), 4 in cohort 3 (2.0 mg/m2), and 4 in cohort 4 (2.5 mg/m2). One pt in cohort 3 experienced a DLT (gr 3 diarrhea). Eight pts experienced gr 3 and 1 pt experienced gr 4 adverse events, including fatigue, vomiting, and diarrhea. The most frequent gr 1 and 2 toxicities were diarrhea and nausea (most likely associated with estramustine). One pt experienced gr 3 anemia; no other pts had severe hematologic toxicity. Preliminary tumor assessment showed 1 pt with PR and 8 pts with SD (3 for 4 months; 5 for 2 months). The MTD of EPO906 in combination with estramustine is 2.5 mg/m2. Conclusion: Preliminary results suggest that EPO906 plus estramustine is generally well tolerated in pts with advanced cancer. Future studies will fully characterize the role of EPO906 in combination with estramustine in the treatment of advanced cancers. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis Pharmaceuticals Corp. Nevada Cancer Institute; Novartis Pharmaceuticals Corp.; Vertex Novartis Pharmaceuticals Corp. Alza Novartis Pharmaceuticals" @default.
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- W2253889655 date "2004-07-15" @default.
- W2253889655 modified "2023-10-14" @default.
- W2253889655 title "Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus estramustine in patients with advanced cancer" @default.
- W2253889655 doi "https://doi.org/10.1200/jco.2004.22.90140.4623" @default.
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