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

Primary Purpose

Non-Small Cell Lung Carcinoma (NSCLC)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ZD1839 (Iressa)
Thoracic Radiotherapy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Carcinoma (NSCLC) focused on measuring Advanced NSCLC, Non-Small Cell Lung Carcinoma, Stage IV NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iressa and RT

Arm 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

Outcomes

Primary Outcome Measures

Patients Affected by Treatment-related Morbidities
See "Adverse Events" section for specific toxicities

Secondary Outcome Measures

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
Progression-free Survival
Survival From Starting Gefitinib

Full Information

First Posted
May 19, 2006
Last Updated
October 19, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00328562
Brief Title
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Carcinoma (NSCLC)
Keywords
Advanced NSCLC, Non-Small Cell Lung Carcinoma, Stage IV NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iressa and RT
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
ZD1839 (Iressa)
Intervention Type
Radiation
Intervention Name(s)
Thoracic Radiotherapy
Primary Outcome Measure Information:
Title
Patients Affected by Treatment-related Morbidities
Description
See "Adverse Events" section for specific toxicities
Time Frame
Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
Secondary Outcome Measure Information:
Title
Tumor Response
Description
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
Time Frame
Baseline, 1, 3, and 5 months post-treatment
Title
Progression-free Survival
Time Frame
Baseline to date of progression
Title
Survival From Starting Gefitinib
Time Frame
Baseline to date of expiration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Werner-Wasik, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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