A Phase II Trial of 9-Aminocamptothecin (NSC 603071) Administered as a 120-Hour Continuous Infusion in Patients With Previously Untreated Gastric Cancer
OBJECTIVES: I. Determine the objective response rate of a 120 hour continuous infusion of
aminocamptothecin (9-AC) in chemotherapy naive patients with adenocarcinoma of the stomach
or gastroesophageal junction. II. Characterize the nature of the toxicity of 9-AC on this
schedule in this patient population. III. Determine the duration of response, time to
progression, and survival of this patient population. IV. Study the pharmacokinetics and
pharmacodynamics of 9-AC on this schedule in these patients.
OUTLINE: This is an open label, multicenter study. Patients receive intravenous
aminocamptothecin by continuous infusion over 120 hours on days 1-5 and 8-12 followed by 1
week of rest for a 3 week cycle. Therapy continues for a minimum of 6 weeks (2 full cycles)
unless there are unacceptable toxic effects or rapid disease progression. Dose escalation
may occur in patients who complete 3 cycles of therapy without unacceptable toxicity. All
patients will be followed for survival.
PROJECTED ACCRUAL: This study will accrue 14-40 patients within 18 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate Objective response rate Objective response rate Objective response rate
4 years
No
Hedy L. Kindler, MD
Study Chair
University of Chicago
United States: Federal Government
9025
NCT00003192
March 1998
August 2003
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |