Lung Cancer
Conditions
Keywords
Lung Cancer
Brief summary
This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.
Detailed description
Upon determination of eligibility all patients will receive: * Docetaxel + Gemcitabine + Cetuximab
Interventions
DRUGGemcitabine
1000mg/m2 30min IV, Day 1 & 8
DRUGDocetaxel
30mg/m2, 30min IV, day 1 & 8
DRUGCetuximab
100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15
Sponsors
Bristol-Myers Squibb
SCRI Development Innovations, LLC
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
To be included in the study, you must meet the following criteria: * 18 years of age or older * Non-small cell lung cancer confirmed by biopsy * Unresectable stage III or IV disease * Measurable disease * Must not have received any prior chemotherapy for lung cancer * Able to perform activities of daily living without considerable assistance * Adequate bone marrow, kidney, and liver function * Signed informed consent
Exclusion criteria
You cannot participate in the study if any of the following apply to you: * History of serious heart disease within six months prior to study entry * Prior treatment with agents that target the EGFR pathway * History of any other uncontrolled or significant disease Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Clinical Response Rate | 18 months | Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 18 months | Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause. |
| Response Duration | 18 months | The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d). | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 51 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age Continuous | 68 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States | 69 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 69 / 69 |
| serious Total, serious adverse events | 43 / 69 |
Outcome results
Primary
Overall Clinical Response Rate
Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.
Time frame: 18 months
Population: Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Overall Clinical Response Rate | 17 Percentage of participants |
Secondary
Progression Free Survival (PFS)
Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.
Time frame: 18 months
Population: All patients were assessed for progression-free survival.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Progression Free Survival (PFS) | 4.0 Months |
Secondary
Response Duration
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Time frame: 18 months
Population: Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Response Duration | 7.0 Months |