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Phase II study of gemcitabine and oxaliplatin in patients with recurrent ovarian cancer: an Australian and New Zealand Gynaecological Oncology Group study
  1. P. Harnett*,
  2. M. Buck,
  3. P. Beale,
  4. A. Goldrick§,
  5. S. Allan,
  6. B. Fitzharris,
  7. P. De Souza#,
  8. M. Links#,
  9. G. Kalimi**,
  10. T. Davies, and
  11. R. Stuart-Harris,
  1. * Department of Medical Oncology, Westmead Hospital, Westmead, New South Wales, Australia
  2. Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia
  3. Department of Medical Oncology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
  4. § Department of Medical Oncology, Liverpool Hospital, Liverpool, New South Wales, Australia
  5. Department of Gynecologic Oncology, Palmerston North Hospital, Palmerston North, New Zealand
  6. Department of Medical Oncology, Christchurch Hospital, Christchurch, New Zealand
  7. # Department of Medical Oncology, Cancer Centre, St George Hospital, Kogarah, New South Wales, Australia
  8. ** Eli Lilly and Company, Indianapolis, Indiana
  9. †† Eli Lilly Australia Pty Ltd, New South Wales, Australia
  10. ‡‡ Department of Medical Oncology, Canberra Hospital, Garran ACT 2605, Australia
  1. Address correspondence and reprint requests to: Paul Harnett, MB, BS, FRACP, PhD, Westmead Hospital, Cnr Hawkesbury and Darcy Roads, Westmead, NSW 2145, Australia. Email: harnettpr{at}


Gemcitabine and oxaliplatin have shown single-agent activity in relapsed ovarian cancer. This combination was used to determine response rates, time-to-event efficacy measures, and toxicity in patients with recurrent ovarian cancer. Patients with prior platinum-based chemotherapy who had measurable lesions and/or elevated CA-125 levels were identified as group A (platinum-refractory/platinum-resistant patients) and group B (platinum-sensitive patients). All patients received gemcitabine 1000 mg/m2 on days 1 and 8 and oxaliplatin 130 mg/m2 on day 8 every 21 days for up to eight cycles. Seventy-five patients (21 in group A and 54 in group B), with a median age of 58 years (range, 37–78), were enrolled. A median of six cycles (range, 1–8) was administered. By intent-to-treat analysis, 15 patients with measurable disease achieved partial response for an overall best response rate of 20.0% (9.5% in group A and 24.1% in group B). CA-125 response was observed in 48.4% patients (30.0% in group A and 57.1% in group B). Median time to progressive disease was 7.1 months (95% CI, 5.6–9.0 months) with 5.0 months in group A and 8.3 months in group B. Median overall survival was 17.8 months (95% CI, 12.9–21.3 months) with 9.2 months for group A and 20.0 months for group B. Major grade 3/4 toxicities were neutropenia (61.3%), leukopenia (24.0%), nausea (16.0%), and vomiting (22.7%). We conclude that the combination of oxaliplatin and gemcitabine is active in patients with recurrent ovarian cancer, but the regimen is unsatisfactory for further study due to modest response and relatively high toxicity.

  • gemcitabine
  • oxaliplatin
  • phase II
  • recurrent ovarian

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