Phase II trial of GTX chemotherapy in metastatic pancreatic cancer

4623 Background: Preclinical studies suggest synergy between gemcitabine (G), docetaxel (T) and capecitabine (X). This GTX regimen was designed to inhibit MEK-ERK phosphorylation and increase BAX and BAK and also decrease BCL-2 in pancreatic cancer cell lines. Based on these findings, we pursued a prospective clinical trial evaluating the activity of GTX in previously untreated patients with metastatic pancreatic cancer. Methods: Patients with histologically confirmed metastatic adenocarcinoma of the pancreas, median age 60, 63% male, ECOG PS 0–2, received capecitabine 1500mg/m2/day total orally in divided doses, days 1 thru 14, gemcitabine 750mg/m2 IV over 75 minutes followed by docetaxel 30mg/m2 IV on days 4 and 11 on a 21 day cycle. Scans were completed every 9 to 10 weeks to assess for tumor response by RECIST criteria. Treatment was continued until evidence of disease progression, intolerable toxicity, surgery or a delay in treatment greater than 6 weeks. The primary endpoint was response rate. Secon...