DOCOX: A phase II trial with docetaxel and oxaliplatin as a second-line systemic therapy for patients with advanced and/or metastatic adenocarcinoma of the pancreas.

Authors

Thomas Ettrich

Thomas Jens Ettrich

Department of Internal Medicine I, University of Ulm, Ulm, Germany

Thomas Jens Ettrich , Goetz von Wichert , Thomas M. Gress , Patrick Michl , Michael Geissler , Holger Frithjof Hebart , Andreas W. Berger , Marc Porzner , Bettina Danner , Rainer Muche , Thomas Seufferlein

Organizations

Department of Internal Medicine I, University of Ulm, Ulm, Germany, Department of Gastroenterology, Philipps-University Marburg, Marburg, Germany, Department of Gastroenterology and Oncology, Klinikum Esslingen, Esslingen, Germany, Klinikum Schwäbisch-Gmünd, Schwäbisch-Gmünd, Germany, Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany

Research Funding

Pharmaceutical/Biotech Company

Background: In Europe and the USA, pancreatic ductal adenocarcinoma (PDAC) is the fifth most common cause of cancer-related death. For patients with metastatic disease, palliative cytostatic systemic treatment is the only option. There is no established standard for 2nd-line treatment. Fluoropyrimidines either alone or in combination with Oxaliplatin or other chemotherapeutic agents are increasingly used. There are interesting data regarding the combination of Gemcitabine with Oxaliplatin or Docetaxel with respect to progression free survival (PFS) and tumor response in 1st-line. For the first time, the DocOx-trial investigates the combination of Oxaliplatin with Docetaxel as 2nd-line treatment after progression under palliative first-line systemic treatment with Gemcitabine. Methods: Prospective, single arm, non-randomized, multicenter, Simon´s two stage phase II trial using Docetaxel (75 mg/m2, 60 min, d 1) plus Oxaliplatin (80 mg/m2, 120 min, d 2, qd 22). Duration of the trial is scheduled up to 8 cycles. Primary endpoint: tumor response (RR) according to RECIST 1.0. Secondary endpoints: PFS, OS, safety/toxicity, QoL/clinical benefit. Results: Here we present the data on response rate (RR), median progression free survival (mPFS) and median overall survival (mOS) as of February 4th, 2013. Data represents the Intention to treat-analysis of the 44 patients included between 2009 and 2012. 5 patients did not obtain any treatment. RR was 16% (7 partial remissions, no complete remission) with a disease control rate (DCR) of 48% after the first two treatment cycles. Median PFS was 7 weeks ( 95%-CI: 6-16 w.) and median OS after start of 2nd-line therapy was 36 weeks ( 95%-CI: 19-55 w.). Conclusions: In this single-arm 2nd-line trial for the treatment of PDAC, the combination of Doxcetaxel and Oxaliplatin shows very promising results compared to other 2nd-line-protocols such as OFF. Some patients seem to benefit particularly as indicated by long periods of treatment in this setting. Even after 8 cycles of treatment with DocOx, partial response was observed in 2 patients and stable disease in another 6 patients corresponding a disease control rate of 18%. Clinical trial information: NCT00690300.

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Pancreatic Cancer

Clinical Trial Registration Number

NCT00690300

Citation

J Clin Oncol 31, 2013 (suppl; abstr 4034)

DOI

10.1200/jco.2013.31.15_suppl.4034

Abstract #

4034

Poster Bd #

15D

Abstract Disclosures