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