NCT00020202

FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer

Phase II Study of FR901228 in Patients With Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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. PROJECTED ACCRUAL: A total of 18-43 patients (9-21 per arm) will be accrued for this study within 18 months.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	FR901228

Timeline

• Start date: 2000-06-01
• Completion: 2007-03-01
• First posted: 2007-03-05
• Last updated: 2024-03-04

Locations

1 site across 1 country: United States