RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy before and after surgery in treating patients with high-risk stomach cancer.

Condition	Treatment or Intervention	Phase
stage III gastric cancer stage II gastric cancer stage IV gastric cancer adenocarcinoma of the stomach	Drug: cisplatin  Drug: floxuridine  Drug: fluorouracil  Drug: leucovorin calcium	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the efficacy and toxicity of neoadjuvant cisplatin/fluorouracil (CDDP/5-FU) followed by surgery followed by adjuvant intraperitoneal floxuridine/leucovorin in patients with high-risk gastric cancer.

II. Assess the quality of life and cost-benefit ratio associated with this treatment.

III. Evaluate the sensitivity, specificity, and overall staging accuracy of laparoscopy with or without laparoscopic ultrasound in predicting the resectability rate (with and without neoadjuvant CDDP/5-FU), response to chemotherapy, and accuracy when compared to pathologic findings.

IV. Correlate the presence of mutated vs. wild-type p53 suppressor oncogenes in endoscopic biopsies and resected tumor specimens with clinical outcome (defined as downstaging, failure pattern, and disease-free and overall survival) in patients treated with and without neoadjuvant CDDP/5-FU.

PROTOCOL OUTLINE: The following acronyms are used: CDDP Cisplatin, NSC-119875 CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 FUDR Floxuridine, NSC-27640

2-Drug Combination Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation. CDDP/5-FU; followed by total or subtotal radical gastrectomy with D2 dissection; followed by FUDR; with CF.

PROJECTED ACCRUAL: A total of 50 patients will be entered over 2-2.5 years.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Microscopically confirmed adenocarcinoma of the stomach or gastroesophageal junction; Reviewed by Department of Pathology of participating institution; Stage II-IV (T2, N1-2, M0 or T3-4, any N, M0) by physical exam, CT, and laparoscopy; Potentially curable by surgery; Suspected sites of metastasis proven M0 prior to entry

--Prior/Concurrent Therapy--

• No prior chemotherapy or radiotherapy

--Patient Characteristics--

• Age: Any age
• Performance status: Karnofsky 60%-100%
• Hematopoietic: WBC at least 4,000; Platelets at least 150,000
• Hepatic: Bilirubin less than 2 mg/dL
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min; BUN no greater than 30 mg/dL
• Cardiovascular: No NYHA class III/IV status; No active angina; No myocardial infarction within 6 months; No significant ventricular arrhythmia requiring medication; No clinically significant conduction system abnormality
• Other: No serious intercurrent infection; No nonmalignant medical illness that is uncontrolled or precludes study participation; No psychiatric disorder that precludes informed consent; No clinically significant auditory impairment; No second malignancy within 5 years except: Basal cell skin cancer; Carcinoma in situ of the cervix; No pregnant or nursing women; Negative pregnancy test required of fertile women; Effective contraception required of fertile patients

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

David Paul Kelsen,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000064831; MSKCC-96027A1; NCI-H96-0916
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002783
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08