A Phase II Trial of Sorafenib and Erlotinib in Unresectable Pancreatic Cancer
- To determine the efficacy of sorafenib tosylate in combination with erlotinib
hydrochloride in patients with unresectable pancreatic cancer.
- 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
- 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
Number of Patients With Progression-free Survival
Number of patients with progression-free survival at 8 weeks
at 8 weeks
Jordan D. Berlin, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0815
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Erlanger Cancer Center at Erlanger Hospital - Baroness||Chattanooga, Tennessee 37403|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|
|Purchase Cancer Group - Paducah||Paducah, Kentucky 42001|
|Baptist Regional Cancer Center at Baptist Riverside||Knoxville, Tennessee 37901|