Oxaliplatin in Gastric Cancer

Phase 2

Completed

• Conditions: Stomach Neoplasms

• Registration Number: NCT00263354
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-07
• Study First Posted: 2005-12-08
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate response rate according to RECIST criteria
To evaluate the progression-free survival in the ITT population

Secondary Outcome Measures

Name	Time	Method
To evaluate the overall survival in the ITT population
To investigate safety using NCI-CTC criteria version 2