Non-Small Cell Lung Cancer
Conditions
Brief summary
* this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added * the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen) * all patients receive all three drugs; there is no placebo
Detailed description
* Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible. * Patients with brain metastases, squamous histology, or hemoptysis are excluded. * All patients must give informed consent. * Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles
Interventions
DRUGbevacizumab
DRUGcarboplatin
DRUGgemcitabine
Sponsors
Genentech, Inc.
Eli Lilly and Company
St. John Providence Health System
Study design
Allocation
NON_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
* Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy * Stage IV disease or stage IIIB with a malignant pleural effusion * measurable or evaluable disease * Performance status 0 or 1 (ECOG) * adequate renal, hepatic, and bone marrow function * adequate recovery from previous surgery or radiotherapy * informed consent
Exclusion criteria
* brain metastases * squamous (epidermoid) histology * hemoptysis * central airway disease * Pancoast tumors * previous chemotherapy or biologic therapy for lung cancer * prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS * pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate | — |
| median survival | — |
| one year survival | — |
| two year survival | — |
| toxicity | — |
Countries
United States
Contacts
Primary ContactMichael J Kraut, MD
Backup ContactJaswinder Grewal, PhD
Outcome results
None listed