Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 Weeks
OBJECTIVES: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors.
II. Assess the qualitative and quantitative toxicity in terms of predictability, duration,
intensity, onset, reversibility, and dose relationship of this treatment regimen in this
patient population. III. Determine a safe dose for phase II evaluation. IV. Assess the
pharmacokinetics of this treatment regimen in these patients. V. Determine any possible
antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour once every 3
weeks. Treatment continues for at least 2 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of E7070 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 12
Primary Purpose: Treatment
Jean-Pierre Armand, MD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government