S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): cisplatin; etoposide; irinotecan hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; 100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles; 60 mg/m2 IV (over 90 min)on Days 1, 8 & 15. Q 4 weeks x 4 Cycles
Intervention MeSH terms: Irinotecan; Etoposide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer