Trial Outcomes & Findings for ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer (NCT NCT00328562)
NCT ID: NCT00328562
Last Updated: 2025-05-04
Results Overview
See "Adverse Events" section for specific toxicities
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Disease progression
|
1
|
Baseline Characteristics
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Iressa and RT
n=13 Participants
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
|
|---|---|
|
Age, Continuous
|
68.75 years
STANDARD_DEVIATION 13.24 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapySee "Adverse Events" section for specific toxicities
Outcome measures
| Measure |
Iressa and RT
n=12 Participants
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
|
|---|---|
|
Patients Affected by Treatment-related Morbidities
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 5 months post-treatmentDefinitions 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
Outcome measures
| Measure |
Iressa and RT
n=12 Participants
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
|
|---|---|
|
Tumor Response
Complete response
|
3 participants
|
|
Tumor Response
Partial response
|
1 participants
|
|
Tumor Response
Minor response
|
3 participants
|
|
Tumor Response
Stable disease
|
1 participants
|
|
Tumor Response
Progressive disease
|
1 participants
|
|
Tumor Response
Not evaluable
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline to date of progressionOutcome measures
| Measure |
Iressa and RT
n=12 Participants
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
|
|---|---|
|
Progression-free Survival
|
5 months
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline to date of expirationOutcome measures
| Measure |
Iressa and RT
n=12 Participants
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
|
|---|---|
|
Survival From Starting Gefitinib
|
10 months
Interval 1.0 to 26.0
|
Adverse Events
Iressa and RT
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iressa and RT
n=12 participants at risk
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
|
|---|---|
|
General disorders
Death
|
41.7%
5/12 • Number of events 5
|
Other adverse events
| Measure |
Iressa and RT
n=12 participants at risk
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
|
|---|---|
|
General disorders
Shoulder pain
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Dysphagia
|
33.3%
4/12 • Number of events 4
|
|
General disorders
Cough
|
25.0%
3/12 • Number of events 3
|
|
General disorders
Nausea
|
25.0%
3/12 • Number of events 3
|
|
General disorders
Diarrhea
|
41.7%
5/12 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
3/12 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
4/12 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
25.0%
3/12 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Increased alkaline phosphatase
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased whole blood count
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Weight loss
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Sensory neuropathy
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Dehydration
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Headache
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Dizziness
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Chest pain
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Side pain
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Bladder pain
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Salivary gland changes
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Alopecia
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Throat pain
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place