The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.
* Cycle 1 and 2: * Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m\^2 intravenous piggy back (IVPB) over 30 min * Days 4, 11 and 25, 32 ....docetaxel 30 mg/m\^2 IVPB over 1 hour * Days 1-14 and 22-35 ....capecitabine 750 mg/m\^2 oral twice daily * Each cycle is 21 days long * SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume * Cycle 3 and 4: * Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m\^2 IVPB over 30 min * Days 54, 61 and 75, 82 ....docetaxel 30 mg/m\^2 IVPB over 1 hour * Days 51-64 ....capecitabine 750 mg/m\^2 oral twice daily * Each cycle is 21 days long * Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14
stereotactic body radiation therapy (SBRT) 25
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Number of Participants With Resectability
The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
Time frame: 6 months per patient
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.
Time frame: 6 months per patient
Number of Participants With Objective Response
Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.
Time frame: 6 months per patient
Number of Participants With Overall Survival
We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.
Time frame: 6 months per patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.