A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

Lilly

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer; SCLC; Carcinoma, Small Cell

Treatments: Radiation: radiation; Drug: pemetrexed; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447421

11089

H3E-EW-S107

Details and patient eligibility

About

The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Measurable disease with diagnosis of Small Cell Lung Cancer.
• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
• Patients must be at least 18 years of age and have at least a 12-week life expectancy.
• No prior chemotherapy and/or prior thoracic radiotherapy.
• Adequate pulmonary function and organ function.

Exclusion criteria

• Patients with myocardial infarction within the preceding six months.
• Diagnosis of a serious concomitant systemic disorder.
• Prior radiotherapy to the lower neck or abdominal region.
• Significant weight loss.
• Concurrent administration of any other antitumor therapy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

A

Experimental group

Treatment:

Drug: pemetrexed

Drug: cisplatin

Radiation: radiation