A Phase II Trial of Neoadjuvant Cisplatin-Fluorouracil-Docetaxel Chemotherapy, Surgery, and Intraperitoneal (IP) Floxuridine (FUdR) Plus Leucovorin in Patients With Locally Advanced Gastric Cancer
OBJECTIVES: I. Determine the efficacy and toxicity of neoadjuvant cisplatin, fluorouracil,
and docetaxel, and postoperative intraperitoneal floxuridine and leucovorin calcium in
patients with locally advanced adenocarcinoma of the stomach or gastroesophageal junction.
II. Determine whether molecular markers, including thymidylate synthase, excision repair
cross complementing gene, and tubulin isoform 4B, for sensitivity to fluorouracil,
cisplatin, and docetaxel, respectively, are predictive of outcome (disease free survival and
overall survival) in these patients. III. Determine the quality of life of these patients
treated with this regimen.
OUTLINE: During weeks 1 and 4, patients receive docetaxel IV over 1 hour followed by
cisplatin IV over 30-60 minutes on day 1, and fluorouracil IV continuously on days 1-5.
During weeks 6-8, patients undergo radical subtotal or total gastrectomy with a D2 lymph
node dissection followed by percutaneous placement of an intraperitoneal port device.
Beginning within 5 days after resection, patients with clear margins receive floxuridine and
leucovorin calcium intraperitoneally on days 1-3 during weeks 1, 3, and 5 in the absence of
disease progression or unacceptable toxicity. Quality of life is assessed prior to beginning
study, prior to surgery, then monthly for 3 months beginning after completion of study
therapy, then every 3 months through year 2, and then every 6 months through year 3.
Patients are followed monthly for 3 months, then every 3 months through year 2, and then
every 6 months though year 3.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2.5 years.
Primary Purpose: Treatment
David Paul Kelsen, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|