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Phase 2 Trial of Docetaxel, Gemcitabine, and Oxaliplatin Combination Chemotherapy in Platinum- and Paclitaxel-Pretreated Epithelial Ovarian Cancer
  1. Gregor Seliger, MD*,,
  2. Lutz P. Mueller, MD,
  3. Thomas Kegel, MD,
  4. Eva J. Kantelhardt, MD*,
  5. Axel Grothey, MD,§,
  6. Regina GroßE, MD*,
  7. Hans-Georg Strauss, MD*,
  8. Heinz Koelbl, MD*,,
  9. Christoph Thomssen, MD* and
  10. Hans-Joachim Schmoll, MD
  1. *Department of Gynecology, Martin Luther University Halle-Wittenberg, Halle, Germany;
  2. Department of Obstetrics and Gynecology, St Elisabeth Hospital, Halle, Germany;
  3. Department of Hematology/Oncology, Martin Luther University Halle-Wittenberg, Halle, Germany;
  4. §Department of Medical Oncology, Mayo Clinic College of Medicine, Rochester, MN; and
  5. Department of Obstetrics and Gynecology, Johannes Gutenberg University, Mainz, Germany.
  1. Address correspondence and reprint requests to Gregor Seliger, MD, Department of Gynecology, Martin Luther University Halle-Wittenberg, Ernst-Grube-Strasse 40, 06097 Halle, Germany. E-mail: gregor.seliger{at}medizin.uni-halle.de.

Abstract

Background: This phase 2 trial was designed to evaluate the efficacy and toxicity of a combination of docetaxel, gemcitabine, and oxaliplatin for platinum- and paclitaxel-pretreated epithelial ovarian cancer.

Patients and Methods: Heavily pretreated patients (N = 30; median age, 61 years) received docetaxel, 55 mg/m2; gemcitabine, 500 mg/m2 (day 1); and oxaliplatin, 70 mg/m2 (day 2) biweekly. Twelve patients had platinum-sensitive disease, and 18 patients had platinum-resistant disease.

Results: Median follow-up was 18.6 months. No differences in patient characteristics were observed between patients with carboplatinum-sensitive and carboplatinum-resistant disease. In patients with carboplatin-sensitive disease, an overall response (OR) of 83.3%, a progression-free survival of 10.6 months, and an overall survival of 18.9 months were observed. In patients with carboplatinum-resistant disease, an OR was seen in 38.9% with a progression-free survival of 5.3 months and an overall survival of 16.3 months. Patients with platinum-refractory disease (progression under previous carboplatinum therapy, n = 13) had an OR of 23%, whereas patients with objective response but relapse less than 6 months after carboplatinum therapy had an OR of 80.0%. Grade 3 and 4 toxicities were only observed for anemia (6.7%), neutropenia (20.0%), thrombopenia, peripheral neuropathy, and diarrhea (16.7%). No neutropenic fever or treatment-related death occurred.

Conclusions: In comparison with current standard protocols, a combination of docetaxel, gemcitabine, and oxaliplatin showed considerably higher efficacy without remarkable increased toxicity; particularly for patients with early relapse after a platinum-containing therapy.

  • Docetaxel
  • Gemcitabine
  • Oxaliplatin
  • Ovarian cancer
  • Platinum-refractory

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Footnotes

  • Funding: No funding was received for this study of any of the authors.

  • Declaration of interests: None of the authors has to declare a commercial interest related to the contents of the study.

  • Statement of author contribution: G.S. and L.P.M. contributed equally to this study. G.S., L.P.M., T.K., A.G., H.K., and H.-J.S. designed the protocol; G.S., L.P.M., and A.G. analyzed the data; G.S., L.P.M., and H.-J.S. wrote the manuscript; and G.S., L.P.M., T.K., E.J.K., A.G., R.G., H.-G.S., H.K., C.T., and H.-J.S. treated the patients and collected the data.

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