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A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere

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Abstract

Purpose

Docetaxel and capecitabine combination is synergistic in preclinical models. We investigated the efficacy and toxicity of this combination as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma (mPC), pretreated with gemcitabine-based chemotherapy.

Methods

Eligible patients were treated with capecitabine 800 mg/m2 orally PO bid on days 1–14 in combination with intravenous docetaxel 30 mg/m2 on days 1 and 8 of each 21-day cycle. The primary end point was overall response rate. Using a three-stage sequential design, two interim analyses for early stopping due to lack of efficacy were planned and conducted after 13 and 26 patients were accrued. Secondary end points included time to treatment failure, progression-free survival (PFS), overall survival (OS) and 50 % drop in CA19-9 levels.

Results

Forty-three patients were evaluable for toxicity and 42 evaluable for response, at a median age of 64 years. The majority of patients (74 %) had ECOG PS 0-1. Six patients (14 %) achieved a partial tumor response, and stable disease for ≥2 cycles was observed in 59 % of patients (n = 25). Thirty-five percent (n = 11/31) of patients had a ≥50 % decrease in CA19-9 levels. The median PFS was 3.7 months (95 % CI 2.1–4.3 months), and the median OS was 5.3 months (95 % CI 4.3–8.6 months). Treatment was generally well tolerated. Grade 3 toxicity and grade 4 toxicity were seen in 45 and 5 % of patients, respectively. One patient had a potential treatment-related mortality.

Conclusions

The combination of capecitabine and docetaxel is active and well tolerated in mPC patients pretreated with gemcitabine-based therapy.

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Acknowledgments

This research is supported by Sanofi-Aventis.

Conflict of interest

The manuscript has never been published and is not under consideration for publication elsewhere. Authors have no financial interest to declare.

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Authors and Affiliations

  1. Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami, 1475 NW 12th Ave St 3300, Miami, FL, 33136, USA

    Heloisa P. Soares, Soley Bayraktar, Jaime Merchan, Jessica Macintyre, Carlos Mayo, Mark R. Green, Orlando Silva, Joe Levi, Gail Walker & Caio M. Rocha-Lima

  2. Tulane University, New Orleans, LA, USA

    Marcelo Blaya

  3. Johns Hopkins Singapore International Medical Center, Singapore, Republic of Singapore

    Gilberto Lopes

Authors
  1. Heloisa P. Soares
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  2. Soley Bayraktar
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  3. Marcelo Blaya
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  4. Gilberto Lopes
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  5. Jaime Merchan
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  6. Jessica Macintyre
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  7. Carlos Mayo
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  8. Mark R. Green
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  9. Orlando Silva
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  10. Joe Levi
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  11. Gail Walker
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  12. Caio M. Rocha-Lima
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Corresponding author

Correspondence to Caio M. Rocha-Lima.

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Soares, H.P., Bayraktar, S., Blaya, M. et al. A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere. Cancer Chemother Pharmacol 73, 839–845 (2014). https://doi.org/10.1007/s00280-014-2414-z

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  • DOI: https://doi.org/10.1007/s00280-014-2414-z

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