Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes.

Abstract

BACKGROUND:

A prospective phase II study was conducted to evaluate the efficacy and toxicity of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer.

PATIENTS AND METHODS:

Patients had a maximum of three prior chemotherapy lines with no more than two prior platinum-containing regimens and a progression-free interval after the last dose of platinum <12 months. A total dose of 4 mg/m(2)/cycle (0.8 mg/m(2)/day from day 1 to day 5) was administered, repeated every 28 days.

RESULTS:

From June 2005 to December 2005, 69 assessable patients were enrolled. The best overall response to study treatment by combined CA-125 and RECIST criteria was partial response in 17 patients (24.6%) and disease stabilization in 22 patients (31.9%). The median time to progression and overall survival were 3.8 and 16.2 months, respectively. A total of 312 cycles were administered. Neutropenia grade 4 and thrombocytopenia grade 4 occurred in 17.4% and 7.2% of patients, respectively. Diarrhea grade 4 was never observed. Asthenia and fatigue were reported by 36.2% and 18.8% of patients, but were all grade 2 or less.

CONCLUSION:

Gimatecan is a new active agent in previously treated ovarian cancer with myelosuppression as main toxicity.

• Authors: S Pecorelli, I Ray-Coquard, O Tredan, N Colombo, G Parma, G Tisi, D Katsaròs, C Lhommé, A A Lissoni, J B Vermorken, A du Bois, A Poveda, L Frigerio, P Barbieri, P Carminati, S Brienza, J P Guastalla
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 21 Issue 4 Pg. 759-765 (Apr 2010) ISSN: 1569-8041 [Electronic] England
• PMID: 19906760 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• ST 1481
• Taxoids
• Platinum
• Camptothecin

Topics

• Administration, Oral
• Adult
• Aged
• Antineoplastic Agents (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Camptothecin (administration & dosage, analogs & derivatives)
• Chemotherapy, Adjuvant
• Fallopian Tube Neoplasms (drug therapy, pathology)
• Female
• Humans
• Middle Aged
• Neoplasms, Glandular and Epithelial (drug therapy, pathology)
• Ovarian Neoplasms (drug therapy, pathology)
• Peritoneal Neoplasms (drug therapy, pathology)
• Platinum (administration & dosage)
• Recurrence
• Taxoids (administration & dosage)