Lung Cancer Clinical Trial
Official title:
Phase II Trial Of Karenitecin (IND 57250) In 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
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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