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.

Russell J. Schilder, John A. Blessing, Mark S. Shahin, David S. Miller, Krishnansu Sujata Tewari, Carolyn Y. Muller, David P. Warshal, Scott McMeekin, Jacob Rotmensch

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1137-1141
Number of pages5
JournalInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society
Volume20
Issue number7
DOIs
StatePublished - Oct 2010

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Platinum
Neoplasms
Therapeutics
Anorexia
irofulven
Neutropenia
Thrombocytopenia
Ovarian Neoplasms
Disease-Free Survival
Appointments and Schedules
Bone Marrow
Kidney
Safety
Drug Therapy
Liver

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. / Schilder, Russell J.; Blessing, John A.; Shahin, Mark S.; Miller, David S.; Tewari, Krishnansu Sujata; Muller, Carolyn Y.; Warshal, David P.; McMeekin, Scott; Rotmensch, Jacob.

In: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, Vol. 20, No. 7, 10.2010, p. 1137-1141.

Research output: Contribution to journalArticle

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abstract = "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.",
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