A Phase II Study of Systemic Therapy With CPT-11 (Camptosar HCl) and Cisplatin in Patients With Advanced Gastric Cancer to be Followed by Surgical Resection and Postoperative Intraperitoneal Chemotherapy
- Determine the complete and partial response rates and time to treatment failure in
patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin
followed by surgery then intraperitoneal floxuridine and cisplatin.
- Determine the rate of potentially curative surgery in patients receiving this regimen.
- Determine the toxicity and tolerance of this regimen in these patients.
OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This
course is repeated 2 weeks later.
Patients who achieve complete or partial remission or stable disease undergo resection 4
weeks after the last chemotherapy dose.
Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP)
chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes
on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Elliot Newman, MD
New York University School of Medicine
United States: Federal Government
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|