Status:
TERMINATED
Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC
Lead Sponsor:
Armando Santoro, MD
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 cance...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven diagnosis of SCLC;
- Limited or extensive-stage disease in patients who have received a single chemotherapy regimen or combined modality (chemotherapy + chest radiotherapy) regimen and relapsed after completion of first-line chemotherapy (sensitive relapse);
- Age \>/= 18 years;
- ECOG Performance Status 0-2;
- Life expectancy of at least 12 weeks;
- Measurable lesions according to RECIST criteria;
- Adequate cardiac, hepatic, renal, and bone marrow function;
- Written informed consent.
Exclusion
- Prior treatment with an HDAC inhibitor;
- Symptomatic and/or unstable pre-existing brain metastases;
- Superior Vena Cava Syndrome;
- Spinal cord compression;
- Severe or uncontrolled medical diseases (Hypertension, diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, or active uncontrolled infections);
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ;
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00697476
Start Date
January 1 2009
End Date
January 1 2010
Last Update
May 29 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089