The Pancreas Center, Clinical Trials

Home > Patient Guide > Clinical Trials

Clinical Trials: Detail

Title:	Phase II Study of Inoperable Nonmetastatic Pancreatic Cancer (Stage IVA) with Neoadjuvant Gemzar, Taxotere and Xeloda (GTX) and Radiation with Gemzar
Trial Start Date:
Trial End Date:
Principal Investigator:	Michael Hall, MD
Description:	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 as well as to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer. The evolution of our GTX regimen was cerefully developed over the past three years from laboratory and clinical work. Many different combinations of these 3 agents were investigated in the laboratory to determine the best combination to achieve biochemical synergy while decreasing the concentration of each drug so as to minimize toxicity to patients without losing the anti-tumor effect.
Criteria:	Inclusion Criteria Criteria: - 18 to 70 years old - Life expectancy >2 months - Histologically confirmed stage IVa adenocarcinoma of the pancreas. (i.e. localized to the pancreas, small bowel, stomach, and/or encasing the superior mesenteric artery, vein or portal vein) - No prior chemotherapy for pancreatic cancer or radiation to the area of the tumor - Measurable disease: any mass reproducibly measurable in two perpendicular diameters by x-ray, phyisical examination, CT or MRI scans - Ineligible for other high priority national or institutional studies - No previous pancreatic resection - If other past surgery, time from surgical recovery is greater than 3 weeks - If of childbearing potential, must consent to using effective contraception while on treatment and for a reasonable period thereafter Exclusion Criteria: - Prior malignancies in the last 5 years - Serious medical or psychiatric illness preventing informed consent - HIV positive - Prior enrollment in investigational trials - History of hypersensitivity to Taxotere or other similar drug (formulated with polysorbate 80)
URL:
Clinical Areas:	Pancreas
Contact:	For more information, please contact Joanna Martinez-Gomez, Phone: 212-305-9337 E-mail: jm2648@columbia.edu

APPOINTMENT CENTER

What to expect from an appointment with a specialist:

Appointment Request Form
Directions to the Center