Stomach Neoplasms
Conditions
Brief summary
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
Interventions
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.
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate - RECIST criteria (unidimensional) | During the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) | During the study conduct |
Countries
Colombia
Outcome results
None listed