Non-Small Cell Lung Carcinoma (NSCLC)
Conditions
Keywords
Advanced NSCLC, Non-Small Cell Lung Carcinoma, Stage IV NSCLC
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.
Interventions
DRUGZD1839 (Iressa)
RADIATIONThoracic Radiotherapy
Sponsors
AstraZeneca
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Progression-free Survival | Baseline to date of progression | — |
| Survival From Starting Gefitinib | Baseline to date of expiration | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
ZD1839 (Iressa)
Thoracic Radiotherapy | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression | 1 |
Baseline characteristics
| Characteristic | Iressa and RT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 68.75 years STANDARD_DEVIATION 13.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 5 / 12 |
Outcome results
Primary
Patients Affected by Treatment-related Morbidities
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iressa and RT | Patients Affected by Treatment-related Morbidities | 12 participants |
Secondary
Progression-free Survival
Time frame: Baseline to date of progression
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Iressa and RT | Progression-free Survival | 5 months |
Secondary
Survival From Starting Gefitinib
Time frame: Baseline to date of expiration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Iressa and RT | Survival From Starting Gefitinib | 10 months |
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
Time frame: Baseline, 1, 3, and 5 months post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iressa and RT | Tumor Response | Complete response | 3 participants |
| Iressa and RT | Tumor Response | Partial response | 1 participants |
| Iressa and RT | Tumor Response | Minor response | 3 participants |
| Iressa and RT | Tumor Response | Stable disease | 1 participants |
| Iressa and RT | Tumor Response | Progressive disease | 1 participants |
| Iressa and RT | Tumor Response | Not evaluable | 3 participants |