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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Drug: Oxaliplatin, 5-Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00611507

L_8107

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)