A Phase I And Randomized Phase 2 Trial Of Epothilone B Analogue BMS 247550 (NSC # 710428) Administered Every 21 Days With Or Without Oral Estramustine Phosphate In Patients With Androgen Independent Prostate Cancer
- Determine the maximum tolerated dose of ixabepilone combined with estramustine in
patients with progressive androgen-independent adenocarcinoma of the prostate. (Phase
- Compare the safety and efficacy of ixabepilone with or without estramustine in this
patient population. (Phase II)
- Correlate the clinical outcomes with reverse transcriptase-polymerase chain
reaction-based assay for prostate-specific antigen mRNA in patients treated with these
OUTLINE: This is a dose-escalation study of ixabepilone (phase I) followed by a randomized,
multicenter study (phase II).
- Phase I: Patients receive ixabepilone IV over 3 hours on day 2 and oral estramustine 3
times daily on days 1-5. Courses repeat every 3 weeks in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity.
- Phase II: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive ixabepilone IV over 3 hours at the MTD on day 2 and
estramustine as in phase I.
- Arm II: Patients receive ixabepilone IV over 3 hours at the MTD on day 1.
Treatment in both arms repeats as in phase I.
Patients are followed every 12 weeks until disease progression.
PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for phase I of this study and a
total of 44-92 patients (22-46 per treatment arm) will be accrued for phase II of this study
within 12-18 months.
Allocation: Randomized, Primary Purpose: Treatment
Michael Morris, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|