A Phase I Open-Label Safety Study of Escalating Doses of Taxol in Combination With Escalating Doses of GEM231 in Patients With Refractory Solid Tumors
OBJECTIVES: I. Determine the safety and maximum tolerated dose of GEM 231 and paclitaxel in
patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor
activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of GEM 231. Patients receive paclitaxel IV over 3
hours on day 1, immediately followed by GEM 231 over 2 hours on days 1, 4, 8, 11, 15, and
18. Treatment continues every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients are treated with one of two doses of paclitaxel and
escalating doses of GEM 231 until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity.
Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A maximum of 1 patient will be accrued per week for this study until the
maximum tolerated dose is reached.
Primary Purpose: Treatment
Sridhar Mani, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|