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

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

Research output: Contribution to journalArticle

7 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)839-845
Number of pages7
JournalCancer Chemotherapy And Pharmacology
Volume73
Issue number4
DOIs
StatePublished - Apr 2014

Keywords

  • Capecitabine
  • Docetaxel
  • Gemcitabine pretreated
  • Pancreatic cancer
  • Second-line chemotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

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    Soares, H. P., Bayraktar, S., Blaya, M., Lopes, G., Merchan, J., Macintyre, J., Mayo, C., Green, M. R., Silva, O., Levi, J., Walker, G., & Rocha-Lima, C. M. (2014). A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere. Cancer Chemotherapy And Pharmacology, 73(4), 839-845. https://doi.org/10.1007/s00280-014-2414-z