ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Carcinoma (NSCLC)
- Interventions
- Drug: ZD1839 (Iressa)Radiation: Thoracic Radiotherapy
- Registration Number
- NCT00328562
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- Histologically confirmed non small cell lung cancer
- Stage IV needing radiation therapy to control symptoms
- Patients with brain metastases
- Unresectable or medically inoperable
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Iressa and RT ZD1839 (Iressa) 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 Iressa and RT Thoracic Radiotherapy 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
- Primary Outcome Measures
Name Time Method Patients Affected by Treatment-related Morbidities 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 Outcome Measures
Name Time Method Survival From Starting Gefitinib Baseline to date of expiration Progression-free Survival Baseline to date of progression Tumor Response Baseline, 1, 3, and 5 months post-treatment 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
Trial Locations
- Locations (1)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States