Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with locally advanced, metastatic, or recurrent cancer of the stomach or esophagus.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of 9-Aminocamptothecin (NSC 603071) Administered as a 120-Hour Continuous Infusion in Patients With Previously Untreated Gastric Cancer|
- Objective response rate Objective response rate Objective response rate Objective response rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 1998|
|Study Completion Date:||August 2003|
|Primary Completion Date:||February 2002 (Final data collection date for primary outcome measure)|
Experimental: Arm A
9-aminocamptothecin (25 mcg/m2/hr x 120hrs, days 1-5 and 8-12 of each 3 week cycle)
Other Name: 9-AC
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003192
|United States, Illinois|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Cancer Care Specialists of Central Illinois, S.C.|
|Decatur, Illinois, United States, 62526|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62701|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Michiana Hematology/Oncology P.C.|
|South Bend, Indiana, United States, 46617|
|Study Chair:||Hedy L. Kindler, MD||University of Chicago|