Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00837876|
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : September 28, 2012
Last Update Posted : June 25, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Sorafenib Drug: Erlotinb||Phase 2|
- 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 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 (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Sorafenib and Erlotinib in Unresectable Pancreatic Cancer|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||November 2012|
Sorafenib + Erlotinib
400 mg taken by mouth 1 time per day.
150 mg taken by mouth 1 time per day.
- Number of Patients With Progression-free Survival [ Time Frame: at 8 weeks ]Number of patients with progression-free survival at 8 weeks
- Response Rate [ Time Frame: 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 [ Time Frame: at 4 months ]Participants with progression-free survival at 4 months.
- Number of Patients With Worst Grade Toxicities [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837876
|United States, Kentucky|
|Purchase Cancer Group - Paducah|
|Paducah, Kentucky, United States, 42002|
|United States, Tennessee|
|Erlanger Cancer Center at Erlanger Hospital - Baroness|
|Chattanooga, Tennessee, United States, 37403|
|Baptist Regional Cancer Center at Baptist Riverside|
|Knoxville, Tennessee, United States, 37901|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center at Franklin|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Jordan D. Berlin, MD||Vanderbilt-Ingram Cancer Center|