Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)

Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer

This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Two 21-day cycles of pemetrexed (500 milligrams per square meter [mg/m2] intravenous [IV] infusion) and carboplatin (target area under the curve [AUC] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray [Gy] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).

Inclusion Criteria:

• Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer
• Measurable disease
• Good performance status
• Adequate bone marrow reserve, hepatic, pulmonary and renal functions

Exclusion Criteria:

• Serious concomitant systemic disorder
• Prior chemotherapy for this cancer and/or prior thoracic radiotherapy
• Pregnancy/breast-feeding
• Significant weight loss over the previous 6 weeks before study entry
• Inability or unwillingness to take vitamin supplementation and corticosteroids