Phase 2 trial of prolonged administration of oral topotecan in platinum/taxane-refractory ovarian, fallopian tube, and primary peritoneal cancers

Gynecologic Oncology
Maurie MarkmanJerome Belinson

Abstract

Preclinical and clinical data have demonstrated the importance of schedule in optimizing the cytotoxic potential of topotecan, one of the most active agents in ovarian cancer. The availability of oral topotecan permits the exploration of the clinical utility of prolonged treatment programs employing this drug. Patients with platinum/taxane resistant ovarian and primary peritoneal cancers were treated with oral topotecan at an initial fixed dose of 1.5 mg/day for 5 days, followed by a 2-day break, with treatment continued on this schedule until disease progression or unacceptable toxicities. Seven patients (median age 61) were entered into this phase 2 trial before further enrollment was discontinued due to the development of excessive side effects (grade 3: fatigue (n = 3); emesis (n = 1), thrombocytopenia with bleeding (n = 1). Two additional patients noted grade 2 fatigue. Four patients experienced reductions in hemoglobin concentrations >4.0 g/dl from baseline during treatment, with two patients requiring red cell transfusions and two receiving recombinant erythropoietin. Three patients developed grade 3 neutropenia, while there were no episodes of > or =grade 2 diarrhea. Three patients exhibited biological evidence of an an...Continue Reading

References

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Sep 10, 2003·Hematology/oncology Clinics of North America·Maurie Markman

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Citations

Feb 24, 2009·Current Medical Research and Opinion·Jalid Sehouli, Gülten Oskay-Ozcelik
Apr 28, 2009·Surgical Oncology·Slavica KvolikLjubica Glavas-Obrovac
Aug 23, 2005·Cancer Chemotherapy and Biological Response Modifiers·Max KreditorHoward S Hochster
May 18, 2006·European Journal of Surgical Oncology : the Journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology·R AgarwalS B Kaye
Apr 22, 2008·The Cochrane Database of Systematic Reviews·L H PengT X Wu

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