S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with paclitaxel, carboplatin, and bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab works in treating patients with advanced non-small cell lung cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer|
- Frequency and severity of hemorrhage toxicities [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Evaluate the frequency and severity of hemorrhage toxicities in patients with advanced non-small cell lung cancer treated with induction therapy comprising cetuximab, paclitaxel, carboplatin, and bevacizumab followed by maintenance therapy comprising cetuximab and bevacizumab.
- Evaluate progression-free and overall survival and response rates (confirmed and unconfirmed, complete and partial) in patients treated with this regimen.
- Determine the frequency and severity of nonhemorrhage toxicities in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Maintenance therapy: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368992
Show 140 Study Locations
|Study Chair:||Edward S. Kim||M.D. Anderson Cancer Center|
|Study Chair:||Roy S. Herbst, MD, PhD||M.D. Anderson Cancer Center|