Phase II Trial of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) 120-Hour Continuous Intravenous Infusion in Advanced Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine whether aminocamptothecin colloidal dispersion (AC/CD) administered
as a 120 hour weekly infusion is an effective treatment for advanced non-small cell lung
cancer. II. Observe any toxicities associated with this treatment in this patient
population.
OUTLINE: Patients receive a 120 hour continuous infusion of aminocamptothecin colloidal
dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are
assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues
indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is
experienced. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer.
120 hour continuous infusion once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy.
No
Nathan Levitan, MD
Study Chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU1597
NCT00003154
January 1998
June 2001
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |