A Randomized, Double Blind Placebo Controlled Phase 2 Study of FOLFOX plus or minus GDC-0449 in patients with advanced gastric and gastroesophageal junction (GEJ) carcinoma

Summary:
Currently, there is no single standard of care chemotherapy regimen for advanced gastric cancer. Of the available treatments, combination chemotherapy provides increased response rates and overall survival at the cost of increased side effects.  Current drugs for gastric cancer include 5-flourouracil, Oxaliplatin, and Cisplatin.  FOLFOX is a treatment regimen consisting of the combination of folinic acid (Leucovorin), 5-flourouracil, and Oxaliplatin.  The purpose of this study is to determine if the addition of GDC-0449 (a drug designed to interrupt cell growth) to FOLFOX chemotherapy improves median progression free survival (PFS) in the first line treatment of patients with advanced gastric and GEJ cancer.

Eligibility and Treatment Plan:

• Age 18 and older
• Patients must have histologically or cytologically confirmed gastric or  GEJ cancer not amenable to surgical resection
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
• No prior chemotherapy for advanced disease.

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