Non-Small Cell Lung Cancer
Conditions
Brief summary
To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
Interventions
DRUGGemcitabine
DRUGCarboplatin
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically positive pleural or pericardial effusion or Stage IV. * No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC. * ECOG Performance Status of 2 . * Patients must be at least 3 weeks since major surgery. Patients must be at least 1 week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy. * Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.
Exclusion criteria
* Any prior radiation therapy to the thoracic area. * Active and ongoing systemic infection. * Prior radiation to greater than 25% of the bone marrow. * ECOG PS other than 2 * Patients with a known hypersensitivity to gemcitabine and carboplatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine and compare the 1-year survival produced by combined Paraplatin (carboplatin) + Gemcitabine versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2 | — |
| To determine the safety of combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2 | — |
| To compare the response rate between treatment groups | — |
| To compare the changes in QOL between treatment groups | — |
Countries
United States
Outcome results
None listed