drugset / Trial / NCT00759824

A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide

NCT00759824

Phase 2 Completed 64 enrolled European Lung Cancer Working Party
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary aim of this study is to determine if the addition of valproic acid to a combination of adriamycin, cyclophosphamide and vindesine could increase progression-free survival in patients relapsing after first-line chemotherapy including platinum derivatives, cisplatin or carboplatin, and etoposide.

Timeline

Start
2008-09
Primary completion
2013-12
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproic Acid Small molecule 20 mg/kg Oral
Subject Valproic Acid Small molecule 30 mg/kg Oral
Background Cyclophosphamide Other / unclassified 1 g Intravenous
Background Doxorubicin Other / unclassified 45 mg/m2 Intravenous
Background Vindesine Small molecule 3 mg/m2 Intravenous