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Completed

NCT Number: NCT00328562

ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for 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.

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Key information

Conditions

Non-Small Cell Lung Carcinoma (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD1839 (IRESSA)

Drug

thoracic radiotherapy

Radiation

Primary outcomes

  1. Patients Affected by Treatment-related Morbidities

    Time frame: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy

    See "Adverse Events" section for specific toxicities

Secondary outcomes

  1. Tumor Response

    Time frame: Baseline, 1, 3, and 5 months post-treatment

    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

  2. Progression-free Survival

    Time frame: Baseline to date of progression

  3. Survival From Starting Gefitinib

    Time frame: Baseline to date of expiration

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2010
First posted
May 22, 2006
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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