NCT00045162

S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles
DRUG	etoposide	100 mg/m2 IV (over 30-60 min) on Days 1 , 2 \& 3. Q 3 weeks x 4 Cycles
DRUG	irinotecan hydrochloride	60 mg/m2 IV (over 90 min)on Days 1, 8 \& 15. Q 4 weeks x 4 Cycles

Timeline

• Start date: 2002-11-01
• Primary completion: 2008-03-01
• Completion: 2009-12-01
• First posted: 2003-01-27
• Last updated: 2018-07-31
• Results posted: 2013-07-09

Locations

408 sites across 2 countries: United States, Canada