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

Lilly

Status and phase: Terminated; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Procedure: radiotherapy; Drug: carboplatin; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494026

H3E-MC-S095

10015

Details and patient eligibility

About

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

Full description

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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Pemetrexed + Carboplatin

Experimental group

Treatment:

Drug: pemetrexed

Procedure: radiotherapy

Drug: carboplatin