drugset / Trial / NCT00317772

Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer

NCT00317772

NaSequentialOpen-labelTreatment

Summary

The purposes of this study are: 1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) weekly of topotecan in combination with standard dose gefitinib in patients with relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are epidermal growth factor receptor (EGF-R) positive (\>/= 1+). 2. To determine the response rate and response duration in this patient population treated with the maximum tolerated dose (MTD) of topotecan administered on a weekly schedule in combination with standard dose gefitinib, given by way of the mouth (PO) daily.

Timeline

Start
2004-09-02
Primary completion
2020-11-04
Completion
2020-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 250 mg
Subject Topotecan Small molecule 2 mg/m2 Intravenous
Subject Topotecan Small molecule 3 mg/m2 Intravenous
Subject Topotecan Small molecule 4 mg/m2 Intravenous