Oxaliplatin in Gastric Cancer

Sanofi

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00263354

L_8915

Details and patient eligibility

About

To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 questionnaire

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)