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

Study Overview
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Brief Summary
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This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer

Official Title
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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

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: Oxaliplatin, 5-Fluorouracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin, 5-Fluorouracil|5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate - RECIST criteria (unidimensional) |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) |  | During the study conduct |