Lung Cancer
Conditions
Keywords
extensive stage small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.
Detailed description
OBJECTIVES: Primary * Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin. Secondary * Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Interventions
DRUGcarboplatin
DRUGirinotecan hydrochloride
Sponsors
Japan Multinational Trial Organization
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Extensive stage disease * Newly diagnosed, treatment-naive disease * At least 1 unidimensionally measurable lesion * No massive pleural or pericardial effusion by chest CT scan * Manageable effusions allowed PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute granulocyte count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * ALT or AST ≤ 2 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine normal Cardiovascular * No myocardial infarction within the past year * No uncontrolled hypertension * No unstable angina * No congestive heart failure * No ventricular arrhythmia requiring medical intervention * No other serious cardiovascular disease Pulmonary * Arterial oxygen pressure (Pa O\_2) ≥ 70 mm Hg * No interstitial pneumonitis or pulmonary fibrosis by chest x-ray Other * Not pregnant or nursing * No uncontrolled diabetes * No severe infection * No paralytic or obstructive ileus * No serious diarrhea * 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 that is in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the chest * Other prior radiotherapy allowed Surgery * At least 2 weeks since prior surgery and recovered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival | — |
| Progression-free survival | — |
Countries
Japan
Outcome results
None listed