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

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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Gefitinib

U.S. FDA Resources

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 (Adult, Senior)
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:

Kimmel Cancer Center at Thomas Jefferson University This link exits the ClinicalTrials.gov site


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:	December 3, 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 Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms	Lung Diseases Respiratory Tract Diseases Gefitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016