drugset / Trial / NCT00117442
A Study of Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to provide dose-finding information regarding the efficacy and kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to determine if carboplatin/paclitaxel can be delivered at a reduced cycle interval when supported by pegfilgrastim-mobilised PBPCs in whole blood.
Timeline
- Start
- 2002-08
- Primary completion
- 2004-08
- Completion
- 2004-12
Publications
- Results Willis F, Theti D, Dean S, Bacon P, Baker N, Pettengell R. Pegfilgrastim successfully mobilizes megakaryocyte progenitors into the peripheral blood in subjects with solid tumours. Bone Marrow Transplant. 2008 Aug;42(3):167-73. doi: 10.1038/bmt.2008.147. Epub 2008 May 26.
- Results Willis F, Woll P, Theti D, Jamali H, Bacon P, Baker N, Pettengell R. Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours. Bone Marrow Transplant. 2009 Jun;43(12):927-34. doi: 10.1038/bmt.2008.411. Epub 2009 Jan 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 12 mg | — |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 18 mg | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |