Pancreatic Cancer Clinical Trial
Official title:
A Phase II Trial of Sorafenib and Erlotinib in Unresectable Pancreatic Cancer
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by
blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more
tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib
works in treating patients with pancreatic cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
- To determine the efficacy of sorafenib tosylate in combination with erlotinib
hydrochloride in patients with unresectable pancreatic cancer.
Secondary
- To determine the response rate in patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen at 4
months.
- To evaluate the safety profile of this regimen in these patients.
- To evaluate the change in serum Ca 19-9 levels at baseline and at 8-week intervals.
- To evaluate the plasma proteomic profile at baseline and at 8 weeks to correlate with
clinical parameters in order to identify potential prognostic or predictive markers.
- To analyze single-nucleotide polymorphisms on DNA obtained from pretreatment blood
samples to evaluate toxicity and response to erlotinib hydrochloride.
OUTLINE: Patients receive oral sorafenib tosylate once or twice daily and oral erlotinib
hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Serum samples are collected at baseline and at 8-week intervals to measure Ca 19-9 levels,
and plasma and buffy coat samples are collected at baseline and at week 8 for proteomic
assessment and genotyping of single-nucleotide polymorphisms associated with response and
toxicity to erlotinib hydrochloride.
After completion of study treatment, patients are followed up every 3 months.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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