Docetaxel plus gemcitabine in combination with capecitabine as treatment for inoperable pancreatic cancer: a phase II study.

PURPOSE

To evaluate the activity and tolerance of gemcitabine in combination with docetaxel and capecitabine in previously untreated patients with advanced pancreatic cancer.

PATIENTS AND METHODS

Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were treated with gemcitabine (1,500 mg/m(2) on days 1 and 15), docetaxel (50 mg/m(2) on days 1 and 15) and capecitabine (2,250 mg/m(2), orally in two daily divided doses, on days 1-7 and 15-21). All three drugs were administered in 4-week cycles, in an initial prospective plan of six cycles. The primary end-point was response rate.

RESULTS

Forty patients were enrolled in the study. At the time of enrollment, 40% of patients had locally advanced and 60% metastatic disease. All patients were evaluable for response and toxicity. On an intent-to-treat analysis, the overall response and disease control rates were 40 and 80%, respectively. The median progression-free survival was 6.0 months, and the median overall survival was 9.0 months. Major grade 3/4 toxicities were neutropenia (17.5%), diarrhea (10%) and hand-foot syndrome (7.5%). There was no treatment-related death.

CONCLUSION

The combination of gemcitabine with docetaxel and capecitabine is feasible and exhibits satisfactory degree of activity in patients with advanced pancreatic cancer, deserving further exploration.