Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer|
- Grade III/IV histological response in tumor specimen rate after induction therapy. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: Yes ]
- Tumor response rate to therapy. [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]Pre and post therapy radiological assessments of the primary tumor will be compared using RECIST criteria.
- Change in CA 19-9 [ Time Frame: Baseline, Day 1 of each cycle, and end of therapy. ] [ Designated as safety issue: No ]Baseline CA19-9 and subsequent levels will be compared.
- Resection rate at surgery [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]The number of patients who have R0 and R1 surgery will be compiled.
- 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. ] [ Designated as safety issue: No ]
- SPARC protein expression in tumor [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Time from the first dose of study drug until date of death from any cause, up to 60 months. ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||May 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Gemcitabine & Abraxane Pancreatic Cancer||
Drug: Gemcitabine and Abraxane
3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298011
|United States, Arizona|
|TGen Clinical Research Services at Scottsdale Healthcare|
|Scottsdale, Arizona, United States, 85258|
|United States, Michigan|
|St Mary's / Trinity Health Care|
|Grand Rapids, Michigan, United States, 49505|
|United States, Minnesota|
|Virginia Piper Cancer Institute|
|Minneapolis, Minnesota, United States, 55408|
|United States, Pennsylvania|
|University of Pittsburg Medical Center|
|Pittsburg, Pennsylvania, United States, 19047|
|Principal Investigator:||Ramesh K. Ramanathan, MD||TGen Drug Development|