A Phase I Study of ZD0473 and Doxil in Patients With Advanced Refractory Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of ZD0473 and doxorubicin HCl liposome
in patients with advanced or metastatic solid tumors or lymphoma. II. Determine the
qualitative and quantitative toxic effects of this regimen in this patient population. III.
Determine the pharmacokinetics of these drugs in this patient population. IV. Determine the
antitumor activity of this regimen in this patient population.
OUTLINE: This is a dose-escalation study. Patients receive doxorubicin HCl liposome IV over
60 minutes followed by ZD0473 IV over 60 minutes on day 1. Treatment repeats every 28 days
for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with partial response (PR) or complete response (CR) may continue treatment until
disease progression or until 2 courses after maximum response. Cohorts of 3-6 patients
receive escalating doses of doxorubicin HCl liposome and ZD0473 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients
experience dose-limiting toxicity. Patients are followed at 4 weeks and 3 months. Patients
with PR or CR ongoing continue follow-up every 3 months until relapse.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Primary Purpose: Treatment
David R. Spriggs, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|