Lung Cancer Clinical Trial
Official title:
Phase II Study Of BBR 3464 As Treatment In Patients With Sensitive Or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen
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 BBR 3464 in treating patients who have
metastatic small cell lung cancer that has not responded to previous treatment.
OBJECTIVES: I. Determine the efficacy of BBR 3464 in terms of response rate in patients with
sensitive or refractory metastatic small cell lung cancer. II. Determine the duration of
response and time to progression in patients treated with this drug. III. Determine the
overall survival of patients treated with this drug. IV. Determine the incidence and
severity of toxic effects of this drug in this patient population. V. Determine the
pharmacokinetics of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients are stratified according to disease
(refractory vs sensitive). Patients receive BBR 3464 IV over 1 hour on day 1. Treatment
repeats every 21 days for at least 3 courses in the absence of disease progression or
unacceptable toxicity. Patients with complete or partial response or stable disease may
receive up to 6 courses of therapy. Patients without progressive disease after 6 courses may
continue treatment at the investigator's discretion. Patients are followed every 9 weeks for
3 years.
PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this
study.
;
Primary Purpose: Treatment
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