Abstract | OBJECTIVE: METHODS: The trial was an open label phase II study. Patients initially enrolled in this study were treated every 14 days with a dose of 24 mg/m2. Unexpected retinal toxicity associated with this dose and schedule lead to modification of the dosing to 0.55 mg/kg on the same schedule with a maximum individual dose of 50 mg. Dose reductions were permitted based on both hematologic and non-hematologic toxicities. RESULTS: Seventy-four women were accrued and stratified into two cohorts including 58 women with platinum-resistant disease and 16 with platinum-sensitive disease. Non-hematologic toxicities included nausea, vomiting, and fatigue. Thirty-one women had between one and six visual symptoms, most were Grade 1 and 2 in nature. The majority of visual toxicities resolved either during treatment or post-treatment with irofulven. There was one partial response in each cohort with 19 (33%) and 8 (50%) of women having stable disease in the platinum-resistant and platinum-sensitive cohorts, respectively. CONCLUSIONS:
Irofulven at 24 mg/m2 on every 14-day schedule is associated with significant retinal toxicity in this patient population. Dosing at 0.55 mg/kg has persistent retinal toxicity, yet demonstrated only limited anti- tumor activity in a population of women who had received extensive prior chemotherapy.
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Authors | Michael V Seiden, Alan N Gordon, Diane C Bodurka, Ursula A Matulonis, Richard T Penson, Eddie Reed, Dave S Alberts, Garry Weems, Michael Cullen, William P McGuire 3rd |
Journal | Gynecologic oncology
(Gynecol Oncol)
Vol. 101
Issue 1
Pg. 55-61
(Apr 2006)
ISSN: 0090-8258 [Print] United States |
PMID | 16260029
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Alkylating
- Organoplatinum Compounds
- Sesquiterpenes
- irofulven
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Alkylating
(adverse effects, therapeutic use)
- Cohort Studies
- Drug Resistance, Neoplasm
- Female
- Humans
- Infusions, Intravenous
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy)
- Organoplatinum Compounds
(pharmacology)
- Ovarian Neoplasms
(drug therapy)
- Sesquiterpenes
(adverse effects, therapeutic use)
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