A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer
OBJECTIVES: I. Determine the safety and tolerability of EMD 121974 in patients with advanced
or metastatic cancer. II. Correlate various surrogate markers of antiangiogenic activity
with EMD 121974 therapy including magnetic resonance imaging and PET scans, serum assays for
various angiogenic and antiangiogenic factors, serum and urine markers of calcium
metabolism, and tumor biopsies.
OUTLINE: This is a dose-escalation study. Patients receive EMD 121974 IV over 1 hour twice
weekly for 4 weeks. Treatment continues for an additional course in the absence of
unacceptable toxicity. Patients with stable or responding disease may continue therapy
indefinitely past the 2 courses until disease progression. Cohorts of 3-6 patients receive
escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
limiting toxicities. Patients are followed every 3 months for the first year, and then every
4 months thereafter until disease progression.
PROJECTED ACCRUAL: A total of 31-40 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety and tolerability of escalating doses of twice weekly EMD 121974 in patients with cancer.
enrollement through termination
Michael S. Gordon, MD
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|