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

Cancer Chemother Pharmacol. 2012 Feb;69(2):477-84. doi: 10.1007/s00280-011-1717-6. Epub 2011 Aug 20.

Abstract

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Anorexia / chemically induced
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Capecitabine
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives
  • Hand-Foot Syndrome / etiology
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / pathology
  • Prospective Studies
  • Treatment Outcome

Substances

  • Deoxycytidine
  • Capecitabine
  • gemcitabine
  • Fluorouracil