* To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer * The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level
age >18 years.
documented gastric adenocarcinoma via histological or cytological examinations;
newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;
no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -
a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;
surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;
severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy
a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;
Phase I Dose-finding Study of Sorafenib Study
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