Study for Inoperable Non-Metastatic Pancreatic CA (Stage IVA) With Neoadjuvant GTX, and Radiation With Gemzar
Pancreatic Cancer Stage IVA
About this trial
This is an interventional treatment trial for Pancreatic Cancer Stage IVA focused on measuring Pancreatic cancer, Gemcitabine, Docetaxel, Capecitabine
Eligibility Criteria
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 < grade 1
- Able to tolerate oral medications
- 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 > 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.
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Experimental
GTX and Radiation Therapy with Gemzar
Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine: A cycle of chemotherapy is made up of 21 days. During each cycle patients will take Xeloda® twice a day for 14 days followed by a rest period of 7 days. On day 4 and 11 (+/- 2 days) of each 21-day cycle patients will also receive Gemzar and Taxotere. Weekly Radiation Therapy with Low-Dose Gemzar Chemotherapy: After completing a total of 3 cycles of GTX chemotherapy each patient will receive 5 weeks of standard radiation therapy in combination with low-dose Gemzar chemotherapy.