Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma
- Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue
should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16
- Locally advanced disease determined by Endoscopic ultrasound, CT scan
(chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET
- No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast),
MRI scan (of abdomen with gadolinium) or PET scan.
- Unresectable tumor. (this reflects those patients whose tumors abut, invade or
surround a major vessel, either venous or arterial or both)
- No prior chemotherapy or radiation therapy.
- Ineligible for other high priority national or institutional studies.
- Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant,
- Must not have other underlying medical conditions that would make them ineligible for
surgery, radiation therapy, or chemotherapy.
- Complete Blood Count and Complete Metabolic Profile:
Absolute Neutrophil Count > 1,500 μl White Blood Count > 3,000/μl Platelet count >
100,000/μl BUN < 1.5 x normal Creatinine < 1.5 normal Hemoglobin > 8.0 g/dl Serum Albumin
> 3 mg/dl Total Bilirubin < 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase < 2.5 x ULN
- Informed consent: Each patient must be completely aware of the nature of his/her
disease process and must willingly give consent after being informed of the nature of
this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.