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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. Secondary endpoints were overall survival (OS) measured as time from start of GTX to death, time to treatment failure (TTF) measured as time from start of GTX to disease progression or other reason for a halt in therapy.


RESULTS
Forty-three patients were enrolled at two centers between May 2004 and January 2007. Forty-one patients were eligible for assessment by intent to treat analysis. 35 patients (85%) had liver metastases. 9 patients (21.9%) had partial responses and 17 patients (41.5%) had stable disease. The one year survival rate was 56%. Two year survival rate was 14.6%. The median OS was 14.5 months. The median TTF was 6.9 months. Grade 3 and 4 toxicities included leukopenia (31.6%), neutropenia (29.2%), thrombocytopenia (12.2%), infection (12.5%), and mucositis (7.5%).


CONCLUSIONS
The combination of gemcitabine, docetaxel, and capecitabine has activity in metastatic pancreatic cancer with a median survival over 1 year. A randomized phase III trial is in planning. [Table: see text].