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

Inclusion Criteria:

• 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 Criteria:

• 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.