Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Condition: Extensive Stage Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: G-CSF; Cisplatin; Etoposide; Irinotecan; Topotecan
Intervention description: G-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery > 10,000 dL.; Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.; Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.; 50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).; Topotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).
Intervention MeSH terms: Cisplatin; Irinotecan; Etoposide; Etoposide phosphate; Topotecan; Podophyllotoxin; Camptothecin; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extensive stage small cell lung cancer; Topotecan; Etoposide; Cisplatin; Irinotecan

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 which combination chemotherapy regimen is more effective in treating
      extensive-stage small cell lung cancer.

      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination
      chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated
             within 2 weeks prior to randomization

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-3

          -  Disease-free for >=5 years if had a prior second malignancy other than treated basal
             cell or squamous cell skin cancer, or carcinoma in situ of the cervix

          -  Adequate hematologic, hepatic and renal function determined by the following tests,
             within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and platelets
             >=100,000/mm3; bilirubin <= upper limit of normal; serum glutamic pyruvate
             transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic
             transaminase (SGOT) or aspartate transaminase( AST) <=2.5 x upper limit of normal if
             no demonstrable liver metastases or <=5 times upper limit of normal in the presence of
             liver metastases; Calculated creatinine clearance >=30 using the formulas in the
             protocol

          -  Age 18 and older

          -  Strongly advised to use an accepted and effective method of contraception

          -  Those with central nervous system (CNS) metastases were eligible if the metastases
             were treated without advancing symptoms prior to the initiation of chemotherapy

          -  Those receiving erythropoietin could continue to receive it

        EXCLUSION CRITERIA:

          -  Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central
             nervous system (CNS) metastases

          -  Prior chemotherapy for this disease

          -  Pregnant or lactating