PHASE II STUDY OF ORAL ETOPOSIDE WITH PHARMACODYNAMIC MODELING IN RELAPSED NON-HODGKIN'S LYMPHOMA (IWF GRADES A-H)
OBJECTIVES: I. Evaluate the response rate and response duration in patients with relapsed
non-Hodgkin's lymphoma when treated with daily oral etoposide. II. Describe the toxic
effects of daily oral etoposide in these patients. III. Monitor etoposide trough levels and
determine whether etoposide concentrations correlate with age, response, and toxicity.
OUTLINE: Patients receive oral etoposide daily for 21 days. Treatment is repeated every 28
days in the absence of disease progression or unacceptable toxicity. Patients in complete or
partial remission receive 2 courses past best response (minimum 6 courses). Patients with
stable disease after 3 courses may be removed from study. Patients are followed every 6
months for 2 years, then annually for survival.
PROJECTED ACCRUAL: Approximately 97 patients will be accrued for this study over 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pharmacodynamics of etoposide
days 8, 15, and 22 of tx
Nancy L. Bartlett, MD
Washington University Siteman Cancer Center
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center||Winston-Salem, North Carolina 27157-1082|
|St. Joseph's Hospital and Medical Center||Paterson, New Jersey 07503|
|Washington University Barnard Cancer Center||Saint Louis, Missouri 63110|