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)

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

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.