A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer
Inclusion Criteria:
- Histologically proven gastric or gastroesophagic junction adenocarcinoma
- Measurable disease at least in a unidimensional manner. If a unique metastasis
constitutes the only disease symptom, histological confirmation will be required
- Metastatic or locally non-surgical primary gastric cancer
- Recurrent gastric cancer after local and/or systemic treatment with a post-surgical
period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant
chemo-radiotherapy of at least 6 months
- Serum bilirubin< 2 mg/dl
- Serum creatinine < or =to 2 times normal superior limit
- Absolute neutrophil count > or =to 2000/dl
- Platelet count > or =to 100000/dl
- Hemoglobin > or =to 10 g/dl
- AST/ALT < or =to 2.5 times normal superior institutional limit
- Alkaline phosphatase < or =to 5 times the normal superior institutional limit
- Age > 18 years
- Performance Status ECOG 0-2
- Written informed consent signed and dated
Exclusion Criteria:
- Symptomatic sensory peripheral neuropathy
- Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial
hypertension)
- Any other malignancy diagnosed within 5 years previous to the gastric cancer, with
the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
- Concomitant anti-tumoral treatment
- Cerebral metastases
- Unstable heart disease, even though under treatment
- Myocardial infarction within the last 6 months
- Pregnancy or nursing (or women in reproductive life without adequate contraception)
- Significant neurological or psychiatric disorders