Cancer Chemotherapy and Pharmacology

, Volume 67, Issue 1, pp 215–221 | Cite as

Phase II study of a fixed dose-rate infusion of gemcitabine associated with erlotinib in advanced pancreatic cancer

  • J. Feliu
  • P. Borrega
  • A. León
  • L. López-Gómez
  • M. López
  • J. Castro
  • C. Belda-Iniesta
  • J. Barriuso
  • V. Martínez
  • M. González-Barón
Clinical Trial Report

Abstract

Purpose

To evaluate the feasibility, toxicity and efficacy of the combination regimen consisting of gemcitabine-FDR infusion plus erlotinib, in ACP patients.

Methods

Forty-two patients with histologically confirmed, locally advanced or metastatic pancreatic cancer were included in this phase II trial. Main objectives were to assess the efficacy and safety of this regimen. Therapeutic regimen consisted of gemcitabine 1,200 mg/m2 in 120-min infusion on days 1, 8 and 15, plus erlotinib 100 mg orally once daily. Cycles were repeated every 28 days.

Results

A total of 160 courses of gemcitabine-FDR erlotinib were administered (median 3.8 courses per patient). The most common grade 3–4 AEs were neutropenia (21%), thrombocytopenia (10%), skin rash (10%) and asthenia (10%). Complete response was achieved in one patient (2%) and 11 (26%) achieved a partial response. Stable disease and progression disease were observed in 11 patients (26%) and 19 (45%), respectively. Median time to progression was 5 months (95%CI: 3.9–5.8 months) and median overall survival was 8 months (95% CI: 5.1–10.8). One-year survival rate was 35%.

Conclusions

A regimen consisting of gemcitabine-FDR infusion plus erlotinib is active and well tolerated in APC patients. However, the results do not justify the conduct of a Phase III trial.

Keywords

Gemcitabine Pancreatic carcinoma Erlotinib FDR 

Notes

Conflict of interest

The authors report no conflict of interest.

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Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • J. Feliu
    • 1
  • P. Borrega
    • 2
  • A. León
    • 3
  • L. López-Gómez
    • 4
  • M. López
    • 5
  • J. Castro
    • 1
  • C. Belda-Iniesta
    • 1
  • J. Barriuso
    • 1
  • V. Martínez
    • 1
  • M. González-Barón
    • 1
  1. 1.Medical Oncology DepartmentHospital Universitario La Paz, IDIPAZMadridSpain
  2. 2.Medical Oncology DepartmentHospital de San Pedro de AlcántaraCaceresSpain
  3. 3.Medical Oncology DepartmentFundación Jiménez DíazMadridSpain
  4. 4.Medical Oncology DepartmentHospital Virgen de la SaludToledoSpain
  5. 5.Medical Oncology DepartmentHospital Infanta SofíaSan Sebastián de Los Reyes, MadridSpain

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