FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have refractory or progressive small cell lung cancer or non-small cell lung cancer.
|Extensive Stage Small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Recurrent Small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer||Drug: FR901228||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of FR901228 in Patients With Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer|
|Study Start Date:||June 2000|
|Study Completion Date:||March 2007|
OBJECTIVES: I. Determine the response of patients with refractory or progressive small cell or non-small cell lung cancer to FR901228.
II. Determine the ability of FR901228 to mediate apoptosis and target gene induction relative to tumor histology in these patients.
III. Determine the toxicity of this treatment in these patients.
PROTOCOL OUTLINE: Patients are stratified according to disease histology (small cell lung cancer vs non-small cell lung cancer).
Patients receive FR901228 IV over 4 hours on days 1 and 7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
A total of 18-43 patients (9-21 per arm) will be accrued for this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020202
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||David S. Schrump||National Cancer Institute (NCI)|