FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00020202|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : August 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Study Completion Date :||March 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020202
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||David S. Schrump||National Cancer Institute (NCI)|