Phase I Study of BMS-214662 and Paclitaxel in Patients With Advanced Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose of BMS-214662 in combination with
paclitaxel in patients with advanced solid tumors. II. Determine the safety and tolerability
of this regimen in these patients. III. Determine the pharmacokinetics of this treatment
regimen in this patient population. IV. Determine the pharmacodynamic effects of this
treatment regimen in serial tumor biopsies in these patients. V. Determine the cytotoxicity
of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study of BMS-214662. Patients receive paclitaxel IV over
3 hours on day 1 and BMS-214662 IV over 1 hour on day 3 of course 1. For all subsequent
courses, patients receive paclitaxel IV over 3 hours followed 30 minutes later by BMS-214662
IV over 1 hour on day 1. Treatment repeats every 3 weeks for at least 2 courses in the
absence of disease progression or unacceptable toxicity. Patients with stable disease or
objectively responding disease receive additional therapy at the investigator's discretion.
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A maximum of 18-21 patients will be accrued for this study within 12-15
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel.
Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Ireland Cancer Center at University Hospitals Case Medical Center||Cleveland, Ohio 44106-5065|