drugset / Trial / NCT00003891
Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients who have advanced solid tumors.
Timeline
- Start
- 1999-02-25
- Primary completion
- 2001-06-08
- Completion
- 2008-09-22
Publications
- Background Goetz AD, Hammond LA, Hao D, et al.: A phase I and pharmacokinetic (PK) study of NX211 (liposomal lurtotecan) administered weekly x 4 every 6 weeks in patients with advanced solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-388, 2002.
- Background Hamilton M, Wolf J, Demetri GD, et al.: Phase I pharmacokinetics of NX211 (liposomal lurtotecan) in patients with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-357, 2002.
- Results Gelmon K, Hirte H, Fisher B, Walsh W, Ptaszynski M, Hamilton M, Onetto N, Eisenhauer E. A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers. Invest New Drugs. 2004 Aug;22(3):263-75. doi: 10.1023/B:DRUG.0000026252.86842.e2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lurtotecan | Small molecule | 0.15 mg/m2 | Intravenous |
| Subject | lurtotecan | Small molecule | 1.5 mg/m2 | Intravenous |
| Subject | lurtotecan | Small molecule | 1.8 mg/m2 | Intravenous |
| Subject | lurtotecan | Small molecule | 2.1 mg/m2 | Intravenous |