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 karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer
OBJECTIVES: * Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy. * Determine the effect of prior response to chemotherapy on response to this drug in these patients. * Determine survival and failure-free survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients. OUTLINE: Patients are stratified according to response to prior chemotherapy (relapsed vs refractory). Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A minimum of 45 patients (25 for stratum I and 20 for stratum II) will be accrued for this study within 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
...and 34 more locations