Study for Inoperable Non-Metastatic Pancreatic CA (Stage IVA) With Neoadjuvant GTX, and Radiation With Gemzar

Inclusion Criteria

• Histologically confirmed adenocarcinoma of pancreas localized to the pancreas, small bowel, stomach and/or encasing the superior mesenteric artery, vein or portal vein. (a.k.a. Stage IV A).
• No prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
• Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.
• Ineligible for other high priority national or institutional studies
• Whipple surgery not allowed. Prior surgery is allowed as long as it was not pancreatic resection (i.e. Whipple surgery) and the time from surgical recovery is greater than three weeks.
• Non pregnant females who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
• Clinical Parameters
• Life expectancy > 2 months.
• Age 18 to 70 years old
• Performance status 0-2 (ECOG). (See Appendix IV)
• Peripheral Neuropathy must be 1,500 μl
• White Blood Count > 3,000/μl
• Platelet count > 100,000/μl
• BUN 8.0 g/dl
• Serum Albumin > 2.5 mg/dl
• Total Bilirubin < 5.0 mg/dl
• SGOT, SGPT, Alkaline Phosphatase < 4.0 x ULN

Exclusion Criteria

• Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
• 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 experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
• Prior malignancies in last 5 years other than: curatively treated carcinoma in-situ of the cervix, non-melanoma skin cancer, prostate or DCIS (ductal carcinoma in-situ) previously treated successfully (cancer free)
• No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
• Patients known to have HIV will be excluded.
• Patients cannot have received any prior investigational agent/therapy, nor will they be allowed any investigational agent/therapy while on protocol.