Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment	Erlotinb	Sorafenib + Erlotinib
Treatment	Sorafenib	Sorafenib + Erlotinib

Primary Outcome Measures

Name	Time	Method
Number of Patients With Progression-free Survival	at 8 weeks	Number of patients with progression-free survival at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Response Rate	at 4 months	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
Number of Patients With Progression-free Survival	at 4 months	Participants with progression-free survival at 4 months.
Number of Patients With Worst Grade Toxicities	every 4 weeks and every 8 weeks in follow-up to resolution of toxicity	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.

Locations (6): Vanderbilt-Ingram Cancer Center - Cool Springs
🇺🇸
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
🇺🇸
Nashville, Tennessee, United States
Purchase Cancer Group - Paducah
🇺🇸
Paducah, Kentucky, United States
Baptist Regional Cancer Center at Baptist Riverside
🇺🇸
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸
Nashville, Tennessee, United States
Erlanger Cancer Center at Erlanger Hospital - Baroness
🇺🇸
Chattanooga, Tennessee, United States