Lung Cancer Clinical Trial
Official title:
Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
yet known whether cisplatin combined with irinotecan is more effective than cisplatin
combined with etoposide in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with
either irinotecan or etoposide in treating patients who have extensive-stage small cell lung
cancer.
OBJECTIVES:
- Compare the survival of patients with extensive stage small cell lung cancer treated
with cisplatin and irinotecan vs cisplatin and etoposide.
- Compare the objective response rate and progression-free survival of patients treated
with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic
effects in these patients.
- Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of
patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number
of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit
of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs
more than 5%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin
IV over 30-60 minutes on day 1. Courses repeat every 4 weeks.
- Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV
over 30-60 minutes on day 1. Courses repeat every 3 weeks.
Treatment in both arms continues for 4 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this
study within 4 years.
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