Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Randomized Phase II Study of BAY 43-9006 in Combination With Gemcitabine in Metastatic Pancreatic Carcinoma
This randomized phase II is studying how well giving sorafenib with or without gemcitabine works in treating patients with metastatic pancreatic cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the objective response rate in patients with metastatic pancreatic cancer
treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by
gemcitabine/BAY 43-9006 at progression.
SECONDARY OBJECTIVES:
I. To determine the six month overall survival rate, 3 month progression free survival rate,
time to tumor progression and overall survival of patients with metastatic pancreatic cancer
treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by
gemcitabine/BAY 43-9006 at progression.
II. To determine the safety profile of gemcitabine and BAY43-9006 in patients with
metastatic pancreatic cancer and compared to those treated with single agent BAY 43-9006.
III. To determine whether mRNA expression levels of genes involved in the gemcitabine
pathway (RR, dck, dcd) and genes involved in the Raf pathway (cyclin D, VEGFR2, p21) will
predict for time to progression, overall survival, and response, in patients with metastatic
pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY
43-9006 followed by gemcitabine/BAY 43-9006 at progression.
IV. To determine whether genomic polymorphisms of genes (measured in peripheral blood
mononuclear cells) involved in the gemcitabine pathway (RR) and genes involved in the ras
pathway (VEGFR2, cyclin D, p21) will predict for time to progression, overall survival,
tumor response, and toxicity in patients with advanced cancer of the pancreas treated with
concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabine/BAY
43-9006 at progression.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
ARM I: Patients receive oral sorafenib twice daily on days 1-28. Patients experiencing
disease progression cross over to Arm II.
ARM II: Patients receive oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on
days 1, 8, and 15.
In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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