drugset / Trial / NCT00317772
Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer
Phase 1/2
Completed
19 enrolled
M.D. Anderson Cancer Center
AstraZeneca · collabGlaxoSmithKline · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |