Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
- Registration Number
- NCT00003192
- Lead Sponsor
- University of Chicago
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A aminocamptothecin 9-aminocamptothecin (25 mcg/m2/hr x 120hrs, days 1-5 and 8-12 of each 3 week cycle)
- Primary Outcome Measures
Name Time Method Objective response rate Objective response rate Objective response rate Objective response rate 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Fort Wayne Medical Oncology and Hematology, Inc.
🇺🇸Fort Wayne, Indiana, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
🇺🇸Decatur, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
Michiana Hematology/Oncology P.C.
🇺🇸South Bend, Indiana, United States