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

  • Clinical Trial Report
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Cancer Chemotherapy and Pharmacology Aims and scope Submit manuscript

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.

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Conflict of interest

The authors report no conflict of interest.

Author information

Authors and Affiliations

  1. Medical Oncology Department, Hospital Universitario La Paz, IDIPAZ, Pº de la Castellana 261, 28046, Madrid, Spain

    J. Feliu, J. Castro, C. Belda-Iniesta, J. Barriuso, V. Martínez & M. González-Barón

  2. Medical Oncology Department, Hospital de San Pedro de Alcántara, Av.Pablo Naranjo, 10003, Caceres, Spain

    P. Borrega

  3. Medical Oncology Department, Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, 28040, Madrid, Spain

    A. León

  4. Medical Oncology Department, Hospital Virgen de la Salud, Avda. Barber, 30, 45004, Toledo, Spain

    L. López-Gómez

  5. Medical Oncology Department, Hospital Infanta Sofía, Paseo de Europa, 34, 28702, San Sebastián de Los Reyes, Madrid, Spain

    M. López

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  1. J. Feliu
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Correspondence to J. Feliu.

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This work is done for Oncopaz Cooperative Group, Spain.

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Feliu, J., Borrega, P., León, A. et al. Phase II study of a fixed dose-rate infusion of gemcitabine associated with erlotinib in advanced pancreatic cancer. Cancer Chemother Pharmacol 67, 215–221 (2011). https://doi.org/10.1007/s00280-010-1472-0

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  • DOI: https://doi.org/10.1007/s00280-010-1472-0

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