drugset / Trial / NCT00186979
Study of ZD1839 Combined With Irinotecan and Vincristine in Pediatric Patients With Refractory Solid Tumors
Phase 1
Completed
34 enrolled
St. Jude Children's Research Hospital
AstraZeneca · collabNational Institutes of Health (NIH) · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in combination with fixed dose of irinotecan and vincristine in patients with refractory solid tumors.
Timeline
- Start
- 2003-05
- Primary completion
- 2010-03
- Completion
- 2010-03
Publications
- Results A Phase I Study of Gefitinib and irinotecan (IRN) in pediatric patients with refractory solid tumors. WL Furman et al. Vol 22, No 14S (July 15 Supplement), 2004: 8521
- Results Effect of Gefitinib on the bioavailability of oral irinotecan in children with refractory solid tumors. K.R. Crews, W.L. Furman, J.C. Panetta, B.B. Freeman, L.C. Iacono, P.J. Houghton, C.F. Stewart. Proceeding of ASCO. Vol 22, No 14S, 2004:2012.
- Results Effect of gefitinib on the systemic dispositon of intravenous irinotecan (IRN) in pediatric patients with refractory solid tumors. L.C. Iacono, W.L. Furman, K.R. Crews, J.C. Panetta, B.B. Freeman, N.C. Daw, C.F. Stewart. Proceedings of ASCO. Vol 22, No 14S, 2004:2011.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gefitinib | Small molecule | 112 mg/m2 | Oral |
| Subject | Gefitinib | Small molecule | 112.5 mg/m2 | Oral |
| Subject | Gefitinib | Small molecule | 150 mg/m2 | Oral |
| Subject | Irinotecan | Small molecule | 15 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1 mg/m2 | — |
| Background | Cefixime | Other / unclassified | 8 mg/kg | Oral |
| Background | Cefpodoxime | Small molecule | — | Oral |