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

A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Carcinoma (NSCLC)
• Intervention / Treatment: Drug: ZD1839 (Iressa); Radiation: Thoracic Radiotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iressa and RT; 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	Drug: ZD1839 (Iressa); Radiation: Thoracic Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Affected by Treatment-related Morbidities	See "Adverse Events" section for specific toxicities	Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response	Definitions of objective tumor response; Complete response - disappearance of all target lesions; Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions; Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started	Baseline, 1, 3, and 5 months post-treatment
Progression-free Survival		Baseline to date of progression
Survival From Starting Gefitinib		Baseline to date of expiration

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Maria Werner-Wasik, MD, Thomas Jefferson University

Publications and helpful links

Helpful Links

• Kimmel Cancer Center at Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 19, 2006
• First Submitted That Met QC Criteria: May 19, 2006
• First Posted (Estimated): May 22, 2006

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Carcinoma; Advanced NSCLC; Stage IV NSCLC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: 03C.225; 2003-07 (Other Identifier: CCRRC); JT 1436 (Other Identifier: JeffTrial Number)