A Randomized Phase II Trial of Cisplatin or Carboplatin With Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the response rates of gemcitabine and carboplatin vs gemcitabine
and cisplatin in patients with stage IIIB, IV, or recurrent non-small cell lung cancer. II.
Determine the toxicity of these two regimens in this patient population. III. Determine the
time to progression and one year survival of these patients on these regimens.
OUTLINE: This is a randomized study. Patients are stratified by stage of disease and gender.
Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV
over 30 minutes on days 1 and 8, followed by carboplatin over 60 minutes on day 1. Arm II:
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by cisplatin IV
over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence
of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months,
every two months for 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study within 1 year.
Allocation: Randomized, Primary Purpose: Treatment
Haralambos Raftopoulos, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government