A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel and Cisplatin or Oxaliplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
I. To evaluate the response rate (CR and PR) of the combination of BAY 43-9006 with
docetaxel and cisplatin or oxaliplatin in patients with gastric and GEJ adenocarcinoma.
II. To evaluate the progression-free survival (PFS) and overall survival. III. To evaluate
the toxicities of BAY 43-9006 in patients with advanced and metastatic gastric or GEJ
adenocarcinoma combined with docetaxel/cisplatin or docetaxel/oxaliplatin.
IV. To evaluate Raf status in the tumor and to correlate response and PFS to the presence or
absence of an activating mutation in B-Raf.
V. To analyze the pharmacokinetic and pharmacogenetic properties of BAY 43-9006 including
angiogenesis, monooxygenases, polymorphisms and MDR. This study will be conducted via the
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
Siewert's tumor location (I vs II vs III) and extent of disease (locally advanced
unresectable vs distant metastases).
Patients receive oral sorafenib twice daily on days 1-21. Patients also receive docetaxel IV
over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response (CR + PR) rate, measured using RECIST criteria
Up to 3 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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