Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	Other	ONC-2007-002 EUDRACT, NCT00697476

Trial Description

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

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Istituto Clinico Humanitas

Armando Santoro

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00697476
Information obtained from ClinicalTrials.gov on April 10, 2009