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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether an experimental drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) when followed by radiation therapy plus low-dose Gemzar, is safe and effective in treating advanced pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Capecitabine; Docetaxel; Gemcitabine

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.