Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00697476|
Recruitment Status : Terminated (insufficient enrollment)
First Posted : June 13, 2008
Last Update Posted : May 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: topotecan, vorinostat||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||January 2010|
Vorinostat/topotecan dose escalation regimen. vorinostat is administered orally once a day for 7 to 14 consecutive days, according to the dose level.Topotecan is administered I.V. for 5 consecutive days every three weeks.
Vorinostat dose levels go from 300 mg/day for 7 days to 400 mg/day for 14 days. Topotecan dose levels go from 1,2 mg/m2 to 1,5 mg/m2
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.
Other Name: Merck Vorinostat
- Maximum tolerated dose of the combination as the recommended dose for phase II trial [Phase I]; objective response rate of the combination [Phase II]; toxicity and safety profile of the combination [Phase II] [ Time Frame: Limiting tolerated dose (Phase I); efficacy/toxicity after the inclusion of the last patient (Phase II) ]
- To assess the antitumor activity of the combination in terms of time to progression (TTP) and overall survival (OS) [Phase II] [ Time Frame: After the follow up period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697476
|Istituto Clinico Humanitas|
|Rozzano, Milan, Italy, 20089|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|