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

Non-Small Cell Lung Carcinoma (NSCLC) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328562
• Other study ID #: 03C.225
• Secondary ID: 2003-07
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2006
• Last updated: December 3, 2014
• Start date: December 2003
• Est. completion date: September 2010

Study information

• Verified date: December 2014
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Carcinoma (NSCLC)

Intervention

Drug:
• ZD1839 (Iressa)

Radiation:
• Thoracic Radiotherapy

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Progression-free Survival		Baseline to date of progression	No
Secondary	Survival From Starting Gefitinib		Baseline to date of expiration	No

External Links

•   Kimmel Cancer Center at Thomas Jefferson University