drugset / Trial / NCT00240097
Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)
Phase 2
Completed
30 enrolled
University of Alabama at Birmingham
Amgen · collabSanofi-Synthelabo · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The primary objective of Part II of the study is to determine the objective tumor response rate of irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed to first line chemotherapy or chemoradiotherapy.
Timeline
- Start
- 2005-06
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |