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
Overview
- Phase
- Phase 1
- Intervention
- ZD1839 (Iressa)
- Conditions
- Non-Small Cell Lung Carcinoma (NSCLC)
- Sponsor
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Patients Affected by Treatment-related Morbidities
- Status
- Completed
- Last Updated
- 12 months ago
Overview
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.
Investigators
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
Arms & Interventions
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
Intervention: ZD1839 (Iressa)
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
Intervention: Thoracic Radiotherapy
Outcomes
Primary Outcomes
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
- Progression-free Survival(Baseline to date of progression)
- Survival From Starting Gefitinib(Baseline to date of expiration)
- Tumor Response(Baseline, 1, 3, and 5 months post-treatment)