Oxaliplatin in Gastric Cancer

Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.

Inclusion Criteria:

• ECOG performance status of 0-2.
• Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
• At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
• First line locally unresectable or metastatic gastric cancer.
• Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
• Serum bilirubin < 2 mg/dl
• Serum creatinine < or = 2 mg/dl
• Hemoglobin > or = 10 g/dl
• Absolute neutrophil count > or = 2000/dl
• Platelet count >or = 100, 000/dl
• AST/ALT < or = 2.5 time-fold the institutional normal upper limit
• Alkaline phosphatase < or = 5 time-fold the institutional normal upper limit
• Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion
• Laboratory tests at least 1 week prior to the first infusion
• Patient available for follow up and able to answer to the quality of life questionnaire

Exclusion Criteria:

• Symptomatic sensorial peripheral neuropathy
• Uncontrolled concomitant disease
• Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
• Concomitant antitumoral treatment
• Cerebral metastases
• Unstable heart disease, even though in treatment
• Myocardial infarction within the last 6 months
• Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months.
• Pregnancy or nursing ( or women in reproductive life without adequate contraception)
• Significant neurological or psychiatric disorders.