Phase II study of melphalan as a single-agent infused over a 24-hour period with individual adapted dosing in patients with recurrent epithelial ovarian cancer

  • Authors:
    • Philippe Mougenot
    • Michel Fabbro
    • Françoise Bressolle
    • Damien Pouessel
    • Stephane Culine
    • Frederic Pinguet
  • View Affiliations

  • Published online on: January 1, 2006     https://doi.org/10.3892/or.15.1.237
  • Pages: 237-241
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Abstract

The current study was performed to evaluate the efficacy and toxicity of a chemotherapy treatment using melphalan administered over a 24-h period with individual adapted dosing in advanced ovarian cancer. Melphalan was infused intravenously with an automatic infusion pump over a 24-h period. The schedule was repeated every 28 days for a maximum of 6 cycles. The initial administered dose was 25 mg/m2. Drug adjustment was then made using a population approach, with the aim of constraining the overall area under the plasma concentration-time curve within 2.0-2.5 mg · h/l. A total of 96 courses of chemotherapy was administered. The toxicity profile did not differ greatly from that reported after a 1-h infusion and was acceptable in such a heavily pretreated patient population. Twenty-five patients were assessable for response and survival. Four (16%) partial responses were observed, which lasted 9, 10, 13 and 37 months, respectively. Three patients experienced stable disease during 8, 14 and 22 months, respectively. The 1- and 2-year survival rates were 18% and 6%, respectively. At the time of analysis, two patients remained alive with progressive disease at 22 and 37 months, respectively. In conclusion, melphalan administered over a 24-h period in platinum- and taxane-resistant ovarian cancer patients appeared to provide some clinical benefits with manageable toxicity. Based on these results, future studies comparing melphalan administered over a 24-h period and oral melphalan administrations will be scheduled.

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January 2006
Volume 15 Issue 1

Print ISSN: 1021-335X
Online ISSN:1791-2431

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Spandidos Publications style
Mougenot P, Fabbro M, Bressolle F, Pouessel D, Culine S and Pinguet F: Phase II study of melphalan as a single-agent infused over a 24-hour period with individual adapted dosing in patients with recurrent epithelial ovarian cancer. Oncol Rep 15: 237-241, 2006.
APA
Mougenot, P., Fabbro, M., Bressolle, F., Pouessel, D., Culine, S., & Pinguet, F. (2006). Phase II study of melphalan as a single-agent infused over a 24-hour period with individual adapted dosing in patients with recurrent epithelial ovarian cancer. Oncology Reports, 15, 237-241. https://doi.org/10.3892/or.15.1.237
MLA
Mougenot, P., Fabbro, M., Bressolle, F., Pouessel, D., Culine, S., Pinguet, F."Phase II study of melphalan as a single-agent infused over a 24-hour period with individual adapted dosing in patients with recurrent epithelial ovarian cancer". Oncology Reports 15.1 (2006): 237-241.
Chicago
Mougenot, P., Fabbro, M., Bressolle, F., Pouessel, D., Culine, S., Pinguet, F."Phase II study of melphalan as a single-agent infused over a 24-hour period with individual adapted dosing in patients with recurrent epithelial ovarian cancer". Oncology Reports 15, no. 1 (2006): 237-241. https://doi.org/10.3892/or.15.1.237