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. Identifier: NCT00020202
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : August 16, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Detailed Description:

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)
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
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Romidepsin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)


--Disease Characteristics-- Histologically or cytologically confirmed primary extensive stage small cell or unresectable non-small cell lung cancer Must have received or refused prior platinum-based chemotherapy and exhibited refractory or progressive disease Tumor must be accessible to biopsy by bronchoscopic or percutaneous fine needle aspiration technique Measurable disease outside of irradiated field or documented progression since irradiation Extrathoracic metastases allowed No active intracranial or leptomeningeal metastases Prior surgical resection or radiotherapy for intracranial metastatic disease allowed if: No evidence of active disease on 2 MRI scans AND No requirement for anticonvulsant medications or steroids to control residual symptoms --Prior/Concurrent Therapy-- Biologic therapy: At least 30 days since prior biologic therapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy, including nitrosoureas or mitomycin, and recovered No prior FR901228 No prior doxorubicin of total dose greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 30 days since prior radiotherapy and recovered At least 4 weeks since prior radiotherapy to the lung or mediastinum Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: PT/PTT normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction greater than 40% No unstable angina, congestive heart failure, or uncontrolled cardiac dysrhythmia No deep vein thrombosis requiring anticoagulation Pulmonary: No pulmonary embolism within past 6 months FEV1 and DLCO greater than 30% predicted pCO2 less than 50 mm Hg on room air pO2 greater than 60 mm Hg on room air Other: HIV negative No active infections Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

Information from the National Library of Medicine

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 identifier (NCT number): NCT00020202

United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: David S. Schrump National Cancer Institute (NCI) Identifier: NCT00020202     History of Changes
Obsolete Identifiers: NCT00005656
Other Study ID Numbers: CDR0000068031
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: August 16, 2013
Last Verified: June 2006

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
recurrent non-small cell lung cancer
stage III non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
stage, non-small cell lung cancer
adult solid tumor
body system/site cancer
extensive stage small cell lung cancer
genetic condition
lung cancer
recurrent small cell lung cancer
small cell lung cancer
solid tumor
stage, small cell lung cancer
thorax/respiratory cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibiotics, Antineoplastic
Antineoplastic Agents