Non-Small-Cell Lung Carcinoma
Conditions
Brief summary
The purposes of this study are to determine: How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer. The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.
Interventions
DRUGGemcitabine
DRUGcisplatin
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Histologically or cytologically confirmed diagnosis of NSCLC * Have provided written informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate organ function
Exclusion criteria
* Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC * Presence of uncontrolled central nervous system (CNS) metastases * Inability to comply with protocol or study procedures * Pregnancy * Breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the objective response rate (ORR) of the standard (30 minute infusion) versus a fixed dose rate (10 mg/m2/minute) of gemcitabine combined with cisplatin as treatment for advanced NSCLC after treatment completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate incidence of laboratory and non laboratory adverse events by maximum Common Toxicity Criteria (CTC) toxicity grade and relationship to study drug of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for | — |
| To evaluate progression-free survival of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for advanced NSCLC. | — |
Countries
Argentina, Brazil, Chile, Mexico
Outcome results
None listed