1 3 Cancer Chemother Pharmacol DOI 10.1007/s00280-014-2414-z ORIGINAL ARTICLE 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 Received: 16 September 2013 / Accepted: 12 February 2014 © Springer-Verlag Berlin Heidelberg 2014 (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 doc- etaxel is active and well tolerated in mPC patients pre- treated with gemcitabine-based therapy. Keywords Pancreatic cancer · Gemcitabine pretreated · Second-line chemotherapy · Capecitabine · Docetaxel Introduction Pancreatic cancer (PC) is the fourth most common cause of cancer-related death in the United States. The estimated incidence of PC is 45,220 cases with 38,460 deaths in the United States in 2013 [1]. Progress in first-line therapy for metastatic pancreas cancer (mPC) in good performance sta- tus patients has recently been made. Both FOLFIRINOX and the combination of gemcitabine and protein-bound paclitaxel improved survival compared to single-agent gemcitabine [2, 3]. Unfortunately, patients will eventually have cancer progression on first-line therapy. Data for second-line chemotherapy in patients with advanced/metastatic PC are limited, and only one rand- omized trial to date reported a survival benefit in patients with gemcitabine-pretreated PC. In this trial, 5-FU, leuco- vorin and oxaliplatin (OFF) were superior to best support- ive care, or to 5-FU alone [4–6]. However, median overall survival (OS) was still disappointing, only 4.8 months with OFF. Therefore, progress is clearly needed. Abstract Purpose Docetaxel and capecitabine combination is syn- ergistic in preclinical models. We investigated the efficacy and toxicity of this combination as second-line chemother- apy in patients with metastatic pancreatic adenocarcinoma (mPC), pretreated with gemcitabine-based chemotherapy. Methods Eligible patients were treated with capecit- abine 800 mg/m 2 orally PO bid on days 1–14 in combina- tion with intravenous docetaxel 30 mg/m 2 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 tox- icity 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 H. P. Soares · S. Bayraktar · J. Merchan · J. Macintyre · C. Mayo · M. R. Green · O. Silva · J. Levi · G. Walker · C. M. Rocha-Lima (*) Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami, 1475 NW 12th Ave St 3300, Miami, FL 33136, USA e-mail: crocha@med.miami.edu M. Blaya Tulane University, New Orleans, LA, USA G. Lopes Johns Hopkins Singapore International Medical Center, Singapore, Republic of Singapore