The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are effective in treating patients with operable pancreatic cancer.
The best outcome for a patient diagnosed with pancreatic cancer is surgery. However many patients have recurrence of the cancer after successful surgery. The investigators are evaluating chemotherapy before surgery, which is a new approach. In this study, Abraxane and gemcitabine will be tested as treatment for people with operable pancreatic cancer to see if surgery can be successfully performed and if treatment will reduce cancer cells in the tumor at surgery. Abraxane is approved by the US FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Gemcitabine is approved by the FDA for first line treatment for patients with locally advanced or metastatic cancer of the pancreas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery.
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States
St Mary's / Trinity Health Care
Grand Rapids, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Grade III/IV histological response in tumor specimen rate after induction therapy.
Time frame: At time of surgery
Number of participants with adverse events.
Time frame: From the initial dose of study drug up to 28 days after last dose of study drug.
Tumor response rate to therapy.
Pre and post therapy radiological assessments of the primary tumor will be compared using RECIST criteria.
Time frame: Baseline and 16 weeks
Change in CA 19-9
Baseline CA19-9 and subsequent levels will be compared.
Time frame: Baseline, Day 1 of each cycle, and end of therapy.
Resection rate at surgery
The number of patients who have R0 and R1 surgery will be compiled.
Time frame: At time of surgery
Time to recurrence
Time frame: Time from first dose of study drug to date of first documented progression or date of death, whichever occurs first, assessed up to 60 months.
SPARC protein expression in tumor
Time frame: At time of surgery
Overall Survival
Time frame: Time from the first dose of study drug until date of death from any cause, up to 60 months.
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