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A Phase 2 Evaluation of Irofulven as Second-line Treatment of Recurrent or Persistent Intermediately Platinum-Sensitive Ovarian or Primary Peritoneal Cancer: A Gynecologic Oncology Group Trial
  1. Russell J. Schilder, MD*,
  2. John A. Blessing, PhD,
  3. Mark S. Shahin, MD,
  4. David S. Miller, MD§,
  5. Krishnansu Sujata Tewari, MD,
  6. Carolyn Y. Muller, MD,
  7. David P. Warshal, MD**,
  8. Scott McMeekin, MD†† and
  9. Jacob Rotmensch, MD‡‡
  1. *Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA;
  2. Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY;
  3. Abington Memorial Hospital, Abington, PA;
  4. §University of Texas Southwestern Medical Center at Dallas, Dallas, TX;
  5. University of California Medical Center, Irvine, CA;
  6. University of New Mexico Cancer Center-South, Albuquerque, NM;
  7. **Cooper Hospital/University Medical Center, Camden, NJ;
  8. ††University of Oklahoma, Oklahoma City, OK; and
  9. ‡‡Rush Presbyterian St Luke's Medical Center, Chicago, IL.
  1. Address correspondence and reprint requests to Russell J. Schilder, MD, Department of Medical Oncology, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111. E-mail: russell.schilder{at}


This multicenter phase 2 trial was conducted by the Gynecologic Oncology Group to evaluate the activity and the safety of irofulven in patients with recurrent epithelial ovarian cancer.

Eligible patients had documented recurrent ovarian cancer 6 to 12 months after receiving a front-line platinum-based regimen and no other chemotherapy. Patients were required to have measurable disease, performance status of 0 to 2, and adequate bone marrow, hepatic, and renal functions before study entry. The dose of irofulven was 0.45 mg/kg intravenously on days 1 and 8 every 21 days. Responses were defined by Response Evaluation Criteria in Solid Tumors.

Fifty-five of 61 enrolled patients were evaluable for response and toxicity. There were 7 partial responses (12.7%), and 30 patients (54.6%) had stable disease. Median progression-free and overall survival were 6.4 months (1.3-37.5 months) and 22.1 months or more (2.8-57.8+ months), respectively. Patients received a median of 3 cycles (range, 1-21) of protocol therapy. Grade 4 hematologic toxicity was limited to reversible neutropenia and thrombocytopenia. Grade 4 nonhematologic toxicity was limited to one patient with anorexia and another with hypomagnesemia.

Irofulven administered at this dose and schedule was well tolerated but had modest activity as a single agent.

  • Irofulven
  • Platinum-sensitive ovarian cancer
  • Primary peritoneal cancer
  • GOG

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  • This study was supported by National Cancer Institute grants CA 27469 (Gynecologic Oncology Group) and CA 37517 (Gynecologic Oncology Group Statistical and Data Center). This study was also supported in part by grants P50 CA083638 (Seiden, PI) and CA006927 (Seiden, PI) from the National Cancer Institute.

  • The following Gynecologic Oncology Group member institutions participated in this study: Abington Memorial Hospital, Walter Reed Army Medical Center, Northwestern University/Feinberg School of Medicine, University of Mississippi, Colorado Gynecologic Oncology Group, University of Pennsylvania Cancer Center, University of Texas Southwestern Medical Center at Dallas, University of California Medical Center at Irvine, Rush Presbyterian St Luke's Medical Center, State University of New York Downstate Medical Center, University of New Mexico Health Sciences Center,Cooper Hospital/University Medical Center, Columbus Cancer Council/Ohio State, University of Massachusetts Memorial Health Care, University of Oklahoma, University of Virginia Health Sciences Center, University of Chicago, Case Western Reserve University, Tampa Bay Cancer Consortium, Gynecologic Oncology Network/Brody School of Medicine, University of Texas-Galveston, and Community Clinical Oncology Program.