Status:
COMPLETED
Oxaliplatin in Gastric Cancer
Lead Sponsor:
Sanofi
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00263354
Start Date
October 1 2003
End Date
July 1 2006
Last Update
November 9 2010
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