Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
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
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer|
|Study Start Date:||April 2001|
|Study Completion Date:||January 2006|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
- 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.
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|Study Chair:||Antonius A. Miller, MD||Comprehensive Cancer Center of Wake Forest University|