Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Intraperitoneal Administration of 9-Amino-20(S)-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity|
|Study Start Date:||August 1998|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003548
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Franco M. Muggia, MD||New York University School of Medicine|