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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Purchase Cancer Group - Paducah
Paducah, Kentucky, United States
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States
Baptist Regional Cancer Center at Baptist Riverside
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Number of Patients With Progression-free Survival
Number of patients with progression-free survival at 8 weeks
Time frame: at 8 weeks
Response Rate
Per RECIST criteria v. 1.0: measurable lesions: CR disappearance of target lesions, PR \> 30% decrease in the sum of the longest diameter (LD) of target lesions, PD \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, SD neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Time frame: at 4 months
Number of Patients With Progression-free Survival
Participants with progression-free survival at 4 months.
Time frame: at 4 months
Number of Patients With Worst Grade Toxicities
Number of patients with worst-grade toxicity at each of five grades (grade 1 to 5, with 5 most severe) following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death.
Time frame: every 4 weeks and every 8 weeks in follow-up to resolution of toxicity
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Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States