Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.
Radiation: Radiation Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer|
- Increase overall survival [ Time Frame: 23 months ] [ Designated as safety issue: No ]Estimated increase in median survival from 11 to 16 months
- Rate of local control [ Time Frame: baseline to average up to 24 weeks ] [ Designated as safety issue: No ]Determine rate of local control from the date of start of treatment to the date of the time of local progression
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2020|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Gemzar/Abraxane and Radiation Therapy
Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.
gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT.
Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks.
Other Name: GemzarDrug: Abraxane
Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT
Other Name: nab-PaclitaxelRadiation: Radiation Therapy
IMRT Dose escalation: 60 Gy (2 Gy/fraction)
Other Name: RT
The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693276
|Contact: UC Cancer Institute||513-584-7698|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: UC Cancer Institute 513-584-7698|
|Principal Investigator: Olugbenga Olowokure, MD|
|Principal Investigator: Michelle Mierzwa, MD|
|Principal Investigator:||Olugbenga Olowokure, MD||University of Cincinnati|
|Principal Investigator:||Michelle Mierzwa, MD||University of Cincinnati|