RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery and intraperitoneal chemotherapy in treating patients who have locally advanced stomach cancer.

Condition	Treatment or Intervention	Phase
stage III gastric cancer stage III esophageal cancer Adenocarcinoma of the Esophagus stage II gastric cancer stage IV gastric cancer stage II esophageal cancer adenocarcinoma of the stomach	Procedure: chemotherapy  Procedure: surgery  Procedure: intraperitoneal therapy  Procedure: conventional surgery  Drug: cisplatin  Drug: docetaxel  Drug: floxuridine  Drug: fluorouracil  Drug: leucovorin calcium	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven locally advanced adenocarcinoma of the stomach or gastroesophageal (GE) junction that is potentially curable by surgery; Patients with tumors involving the GE junction must have the bulk of their disease in the stomach; No tumors of the distal esophagus or GE junction that extend less than 2 cm into the stomach; Tumor stage T2, N1-2, M0 OR T3-4, any N, M0 by physical exam, CT scan, and laparoscopy

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: Any age
• Performance status: Karnofsky 60-100%
• Life expectancy: Not specified
• Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 150,000/mm3
• Hepatic: Bilirubin less than 2 mg/dL; SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN; Ineligible if SGOT and SGPT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN
• Renal: Blood urea nitrogen no greater than 30 mg/dL; Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance greater than 50 mL/min
• Cardiovascular: No New York Heart Association class III or IV heart disease; No active angina or myocardial infarction within the past 6 months; No history of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
• Other: No clinically significant auditory impairment; No worse than grade 2 preexisting peripheral neuropathy; No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy; No psychiatric disorder that would preclude compliance

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:  CDR0000068053; MSKCC-99066; NCI-G00-1813
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00006038
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08