NCT00697476

Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC

Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Armando Santoro, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the maximum tolerated dose, the activity and the safety profile of the combination of vorinostat and topotecan in patients with recurrent small cell lung cancer

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	topotecan, vorinostat	Phase I study: vorinostat will be administered daily for a number of days per cycle variable from 7 to 14 according to the level of dose escalation; topotecan will be administered I.V. for 5 consecutive days every 3 weeks. Phase II study: Patients will receive treatment at the recommended dose established by phase I part of the trial, for a maximum of 6 cycles or until disease progression, unacceptable toxicity or patient's refusal.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-09-01
• Completion: 2010-01-01
• First posted: 2008-06-13
• Last updated: 2013-05-29

Locations

1 site across 1 country: Italy