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
Intervention: cisplatin; etoposide; irinotecan hydrochloride
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 671.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: extensive stage small cell lung cancer

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed extensive stage small cell lung cancer
             (SCLC)

          -  Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam

          -  Brain metastases allowed if previously treated with radiotherapy and/or surgery and
             are neurologically stable (i.e., no progressing symptoms and off steroids and
             anticonvulsants)

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC at least 3,000/mm^3

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST or ALT no greater than 2.5 times ULN

        Renal

          -  Creatinine normal

          -  Creatinine clearance at least 50 mL/min

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

          -  HIV negative

          -  No concurrent AIDS-related illness

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior biologic therapy for SCLC

          -  No filgrastim (G-CSF) within 24 hours of chemotherapy

        Chemotherapy

          -  No prior systemic chemotherapy for SCLC

        Endocrine therapy

          -  See Disease Characteristics

        Radiotherapy

          -  See Disease Characteristics

          -  At least 21 days since prior brain radiotherapy and recovered

          -  No other prior radiotherapy for SCLC

        Surgery

          -  See Disease Characteristics

          -  At least 21 days since prior thoracic or other major surgery and recovered

        Other

          -  No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital,
             oxcarboxepine, or carbamazepine)