ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Non-Small Cell Lung Carcinoma (NSCLC)

Treatments: Radiation: Thoracic Radiotherapy; Drug: ZD1839 (Iressa)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00328562

JT 1436 (Other Identifier)

2003-07 (Other Identifier)

03C.225

Details and patient eligibility

About

The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.

Full description

To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.

To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed non small cell lung cancer
• Stage IV needing radiation therapy to control symptoms
• Patients with brain metastases
• Unresectable or medically inoperable

Exclusion criteria

• Small cell lung cancer
• Previous thoracic radiation therapy
• Oxygen-dependent patients
• Forced expiratory volume in 1 second (FEV1) less than 1.5
• Patients with active interstitial lung disease
• Patients with underlying lung disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Iressa and RT

Experimental group

Description:

Iressa plus thoracic RT at the following dose levels: * Level 1: 42.0 Gy in 10 fractions of 4.2 Gy * Level 2: 50.4 Gy in 12 fractions of 4.2 Gy * Level 3: 63.0 Gy in 15 fractions of 4.2 Gy

Treatment:

Drug: ZD1839 (Iressa)

Radiation: Thoracic Radiotherapy