A Phase I Pharmacokinetic Study of Single Dose Intravenous CA4P in Patients With Advanced Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of combretastatin A4 phosphate when
administered at single doses every 21 days in patients with advanced solid tumors. II.
Determine both the toxicity and dose limiting toxicity of this regimen in these patients.
III. Determine the plasma and urine pharmacokinetics of combretastatin A4 and combretastatin
A4 phosphate. IV. Gather preliminary data regarding possible antitumor effects in those
patients with measurable disease.
OUTLINE: This is an open label, dose escalation study. Patients receive combretastatin A4
phosphate IV over 10-60 minutes. Treatment repeats every 3 weeks in the absence of
unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating
doses of combretastatin A4 phosphate 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 toxicity. Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A maximum of 21 patients will be accrued for this study.
Primary Purpose: Treatment
Scot C. Remick, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|