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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: European Lung Cancer Working Party · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Adriamycin, cyclophosphamide, vindesine, valproic acid	Adriamycin 45 mg/m² day 1 IV Cyclophosphamide 1 g/m² day 1 IV Vindesine 3 mg/m² day 1 IV Valproic acid 20-30 mg/kg/day from day -7 until the end of treatment, orally

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2008-09-25
• Last updated: 2015-02-12

Locations

5 sites across 1 country: Belgium