drugset / Trial / NCT00252889
Doxil Topotecan Doublet Cancer Study
Phase 1
Completed
20 enrolled
Christiana Care Health Services
GlaxoSmithKline · collabJohnson & Johnson · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective is to determine the nature and degree of the toxicity of weekly dosing of topotecan in escalating dose levels by cohorts of 3-6 patients in combination with a fixed dose of pegylated liposomal doxorubicin (Doxil). The secondary objective is to determine the activity of weekly topotecan and pegylated liposomal doxorubicin in advanced solid tumors.
Timeline
- Start
- 2004-05
- Primary completion
- 2006-03
- Completion
- 2008-06
Publications
- Results Masters GA, et. al., A Phase I Study of Pegylated Doxorubicin (DOX) and Weekly Topotecan (TOP) in Patients (pts) with Advanced Solid Tumors. ASCO Abstract, submitted 12/14/05.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | — |
| Subject | Topotecan | Small molecule | — | Intravenous |