Cancer Chemotherapy and Pharmacology

, Volume 64, Issue 6, pp 1173–1179

Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer

Authors

  • Hui-Ju Ch’ang
    • National Institute of Cancer ResearchNational Health Research Institutes
    • Department of Radiation OncologyNational Cheng-Kung University Hospital
  • Chin-Lun Huang
    • Department of OncologyNational Taiwan University Hospital
  • Hsiu-Po Wang
    • Department of Internal MedicineNational Taiwan University Hospital
  • Her-Shyong Shiah
    • National Institute of Cancer ResearchNational Health Research Institutes
    • Department of Internal MedicineNational Cheng-Kung University Hospital
  • Ming-Chu Chang
    • Department of Internal MedicineNational Taiwan University Hospital
  • Chang-Ming Jan
    • Department of Internal MedicineKaohsiung Medical University Hospital
  • Jen-Shi Chen
    • Department of OncologyChang Gung Memorial Hospital
  • Yu-Wen Tien
    • Department of SurgeryNational Taiwan University Hospital
  • Tsann-Long Hwang
    • Department of SurgeryChang Gung Memorial Hospital
  • Jaw-Town Lin
    • Department of Internal MedicineNational Taiwan University Hospital
  • Ann-Lii Cheng
    • Department of OncologyNational Taiwan University Hospital
    • Department of Internal MedicineNational Taiwan University Hospital
  • Jacqueline Whang-Peng
    • National Institute of Cancer ResearchNational Health Research Institutes
    • National Institute of Cancer ResearchNational Health Research Institutes
    • Department of Internal MedicineNational Cheng-Kung University Hospital
    • Department of Internal MedicineKaohsiung Medical University Hospital
Original Article

DOI: 10.1007/s00280-009-0980-2

Cite this article as:
Ch’ang, H., Huang, C., Wang, H. et al. Cancer Chemother Pharmacol (2009) 64: 1173. doi:10.1007/s00280-009-0980-2

Abstract

Purpose

To evaluate the efficacy and safety profile of a triplet regimen consisting of gemcitabine, oxaliplatin, and infusional fluorouracil and leucovorin (LV) in advanced pancreatic carcinoma (APC).

Patients and methods

Chemotherapy-naïve patients with histo-/cytologically proven unresectable APC, and bi-dimensionally measurable diseases were eligible. Treatment consisted of fixed-dose rate (10 mg/m2/min) infusion of 800 mg/m2 gemcitabine followed by 2-h infusion of 85 mg/m2 oxaliplatin and then 48-h infusion of fluorouracil and LV (3,000 and 300 mg/m2, respectively) every 2 weeks (the GOFL regimen). The primary end-point was objective response rate.

Results

Forty-five patients were enrolled and received a median of seven [95% confidence interval (CI) 6.4–8.8] cycles of treatment. On intent-to-treat analysis, the overall response and disease-control rates were 33.3% (95% CI 21.4–48.0%) and 68.9% (95% CI 54.8–83.0%), respectively. Clinical benefit response was observed in 46.2% of initially symptomatic patients. The median time-to-tumor progression and overall survival were 5.1 (95% CI 4.0–6.3) months and 8.7 (95% CI, 6.1–11.3) months, respectively. Major grade 3–4 toxicities were neutropenia (28.9%, with 4.4% complicated with fever), peripheral sensory neuropathy (15.6%), nausea/vomiting (13.3%), and diarrhea (6.7%).

Conclusions

The triplet regimen is feasible and exhibits promising activity against APC, deserving further exploration.

Keywords

GemcitabineOxaliplatinFluorouracilPancreatic cancerPhase II

Copyright information

© Springer-Verlag 2009