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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00328562
First received: May 19, 2006
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Carcinoma (NSCLC)
Drug: ZD1839 (Iressa)
Radiation: Thoracic Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    See "Adverse Events" section for specific toxicities


Secondary Outcome Measures:
  • Tumor Response [ Time Frame: Baseline, 1, 3, and 5 months post-treatment ] [ Designated as safety issue: No ]

    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

  • Progression-free Survival [ Time Frame: Baseline to date of progression ] [ Designated as safety issue: No ]
  • Survival From Starting Gefitinib [ Time Frame: Baseline to date of expiration ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: December 2003
Study Completion Date: September 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328562

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
AstraZeneca
Investigators
Principal Investigator: Maria Werner-Wasik, MD Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00328562     History of Changes
Other Study ID Numbers: 03C.225, 2003-07
Study First Received: May 19, 2006
Results First Received: June 9, 2014
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Advanced NSCLC
Non-Small Cell Lung Carcinoma
Stage IV NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014