Oxaliplatin in Gastric Cancer

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Oxaliplatin

Criteria

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.