Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity
OBJECTIVES: I. Determine the qualitative and quantitative toxicities of intraperitoneal
aminocamptothecin colloidal dispersion administered every 28 days in 6 applications over a
12 day period in patients with advanced cancer confined to the peritoneal cavity. II.
Determine the maximum tolerated dose of aminocamptothecin colloidal dispersion on this novel
schedule in this patient population. III. Obtain pharmacological and biochemical data as
potential predictors of responses and/or drug toxicities in these patients. IV. Document the
presence and degree of antitumor activity of this regimen in this patient population.
OUTLINE: This is a dose escalation study. Patients receive intraperitoneal aminocamptothecin
colloidal dispersion (9-AC) over 30-60 minutes in 6 applications over a 12 day period (days
1, 3, 5, 8, 10, and 12). Courses are repeated every 28 days. Treatment continues for 4-6
courses in the absence of unacceptable toxic effects or disease progression. The dose of
9-AC is escalated in cohorts of 3-6 patients 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 until death.
PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for this study within 18
Primary Purpose: Treatment
Franco M. Muggia, MD
New York University School of Medicine
United States: Federal Government
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|