Phase I/II study of tandem cycles of high-dose chemotherapy followed by autologous hematopoietic stem cell support in women with advanced ovarian cancer

A. Tiersten, M. Selleck, D. H. Smith, I. Wertheim, E. Kaufman, D. Hershman, L. T. Vahdat, D. G. Savage, R. B. MacArthur, C. Hesdorffer

Research output: Contribution to journalArticle

Abstract

The objectives of this study were to investigate the tolerability of a novel high-dose chemotherapy (HDC) regimen with peripheral blood progenitor cell (PBPC) support in patients with pretreated advanced ovarian cancer and to determine the maximum-tolerated dose (MTD) of topotecan in this setting. Advanced ovarian cancer patients previously treated with platinum-based first-line therapy were enrolled. After PBPC mobilization and harvesting, patients received three consecutive cycles of HDC with PBPC support. Cycle 1 was carboplatin area under the concentration curve 20 and paclitaxel 250 mg/m 2. Cycle 2 was topotecan starting at 5 mg/m2, dose escalated in 2 mg/m2 increments, and etoposide 600 mg/m2. Cycle 3 was thiotepa 500 mg/m2. After each cycle, PBPCs were infused. Granulocyte colony stimulating factor (5 μg/kg/day) was administered until neutrophil recovery occurred. Seventeen patients were enrolled; all were safety evaluable. The most common nonhematologic toxicity was grade 3 mucositis (44%). Engraftment of PBPCs was successful in all patients after each cycle, and no treatment-related deaths occurred. Of 14 patients with measurable disease, 5 (36%) had complete responses, 2 (14%) had partial responses, and 4 (29%) had stable disease. The median progression-free and overall survivals were 7 and 18 months, respectively. The MTD of topotecan was not reached. The tolerability and activity of this regimen in patients with advanced ovarian cancer warrant further investigation.

Original languageEnglish (US)
Pages (from-to)57-64
Number of pages8
JournalInternational Journal of Gynecological Cancer
Volume16
Issue number1
DOIs
StatePublished - Jan 1 2006

Keywords

  • Carboplatin
  • High-dose chemotherapy
  • Ovarian cancer
  • Paclitaxel
  • Thiotepa
  • Topotecan

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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    Tiersten, A., Selleck, M., Smith, D. H., Wertheim, I., Kaufman, E., Hershman, D., Vahdat, L. T., Savage, D. G., MacArthur, R. B., & Hesdorffer, C. (2006). Phase I/II study of tandem cycles of high-dose chemotherapy followed by autologous hematopoietic stem cell support in women with advanced ovarian cancer. International Journal of Gynecological Cancer, 16(1), 57-64. https://doi.org/10.1111/j.1525-1438.2006.00278.x