Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer

Phase 1/2 Terminated 30 enrolled Daniela Matei, MD Bayer · collab Hoosier Cancer Research Network · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is platinum-resistant (recurrence within 6 months from completing platinum based therapy) or refractory (progressive disease during platinum based therapy).

Timeline

Start: 2007-09
Primary completion: 2010-01
Completion: 2010-08

Outcome

Outcome not reported

Stopped (Enrollment): “Study closed to accrual due unfavorable interim analysis”

Publications

Background Matei D, Emerson RE, Schilder J, Menning N, Baldridge LA, Johnson CS, Breen T, McClean J, Stephens D, Whalen C, Sutton G. Imatinib mesylate in combination with docetaxel for the treatment of patients with advanced, platinum-resistant ovarian cancer and primary peritoneal carcinomatosis : a Hoosier Oncology Group trial. Cancer. 2008 Aug 15;113(4):723-32. doi: 10.1002/cncr.23605.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	200 mg	Oral
Subject	Sorafenib	Small molecule	400 mg	Oral
Subject	Topotecan	Small molecule	3.5 mg/m2	—