Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study

Fecha de inicio: 1 de noviembre de 2003

1. Histologically or cytologically documented small cell lung cancer of limited stage. 1.1 Limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes. 1.2 Although they are usually defined as having limited stage small cell lung cancer, because of concern about the volume of the radiation field that would be required, patients with clinically suspected or confirmed supraclavicular lymph node metastases, patients with pathologically enlarged contralateral hilar lymph nodes, and patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are NOT eligible. 2. All Patients must have Measurable Disease 2.1 Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan. 2.2 Pleural/pericardial effusions are not considered measurable. 3. Age ≥18 4. ECOG Performance status 0-2. 5. Prior Treatment - No prior chemotherapy or radiotherapy for SCLC. 6. No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. 7. Non-pregnant and non-nursing because of significant risk to the fetus/infant. 8. Required Initial Laboratory Values * Granulocytes ≥1,500/µl * Platelets ≥100,000/µl * Serum Creatinine ≤ULN * Bilirubin \<1.5 mg/dl * SGOT (AST) \<2 x ULN