A Phase I Open-Label Safety Study of Escalating Doses of Taxotere in Combination With Escalating Doses of GEM231 in Patients With Refractory Solid Tumors
OBJECTIVES: I. Determine the safety and maximum tolerated dose of docetaxel and GEM 231 in
patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor
activity of GEM 231 in this patient population.
OUTLINE: This is a dose escalation study of GEM 231 and docetaxel. Patients receive
docetaxel IV over 1 hour on day 1, immediately followed by GEM 231 IV over 2 hours on days
1, 4, 8, and 11. Treatment continues every 3 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of GEM 231
and docetaxel 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