Cancer Chemotherapy and Pharmacology

, Volume 64, Issue 6, pp 1173–1179 | Cite as

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

  • Hui-Ju Ch’ang
  • Chin-Lun Huang
  • Hsiu-Po Wang
  • Her-Shyong Shiah
  • Ming-Chu Chang
  • Chang-Ming Jan
  • Jen-Shi Chen
  • Yu-Wen Tien
  • Tsann-Long Hwang
  • Jaw-Town Lin
  • Ann-Lii Cheng
  • Jacqueline Whang-Peng
  • Li-Tzong Chen
Original Article

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

Gemcitabine Oxaliplatin Fluorouracil Pancreatic cancer Phase II 

Notes

Acknowledgment

Supported by grants (CA094-PP-04 and CA095-CP-06) from the National Health Research Institutes, Zhunan, Taiwan.

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Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Hui-Ju Ch’ang
    • 1
    • 2
  • Chin-Lun Huang
    • 4
  • Hsiu-Po Wang
    • 5
  • Her-Shyong Shiah
    • 1
    • 3
  • Ming-Chu Chang
    • 5
  • Chang-Ming Jan
    • 7
  • Jen-Shi Chen
    • 8
  • Yu-Wen Tien
    • 6
  • Tsann-Long Hwang
    • 9
  • Jaw-Town Lin
    • 5
  • Ann-Lii Cheng
    • 4
    • 5
  • Jacqueline Whang-Peng
    • 1
  • Li-Tzong Chen
    • 1
    • 3
    • 7
  1. 1.National Institute of Cancer ResearchNational Health Research InstitutesTainanTaiwan
  2. 2.Department of Radiation OncologyNational Cheng-Kung University HospitalTainanTaiwan
  3. 3.Department of Internal MedicineNational Cheng-Kung University HospitalTainanTaiwan
  4. 4.Department of OncologyNational Taiwan University HospitalTaipeiTaiwan
  5. 5.Department of Internal MedicineNational Taiwan University HospitalTaipeiTaiwan
  6. 6.Department of SurgeryNational Taiwan University HospitalTaipeiTaiwan
  7. 7.Department of Internal MedicineKaohsiung Medical University HospitalKaohsiungTaiwan
  8. 8.Department of OncologyChang Gung Memorial HospitalTaoyuanTaiwan
  9. 9.Department of SurgeryChang Gung Memorial HospitalTaoyuanTaiwan

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