Cisplatin, Etoposide & Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as 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 deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer|
- Percentage of Participants Alive and Progression-free (PF) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.
- Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year ] [ Designated as safety issue: No ]Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored.
- Best Objective Response [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]Number of patients with complete or partial response by RECIST criteria.
|Study Start Date:||June 2004|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Experimental: Cisplatin, Etoposide & Bevacizumab||
15 mg/kg IV infusion over 90 minutes day 1 of a 21-day cycle
Other Name: AvastinDrug: cisplatin
60 mg/m2 IV over 30-60 minutes day 1 of a 21-day cycleDrug: etoposide
120 mg/m2 IV over 60 minutes days 1, 2, and 3 of a 21-day cycle
I. Determine the 6-month progression-free survival of patients with previously untreated extensive stage small cell lung cancer treated with cisplatin, etoposide, and bevacizumab.
II. Determine the 6-month survival and response rate in patients treated with this regimen.
III. Determine the toxicity of this regimen in these patients.
I. Correlate pretreatment plasma levels of vascular endothelial growth factor (VEGF) with response and progression-free and overall survival of patients treated with this regimen.
II. Correlate elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin) with response in patients treated with this regimen.
III. Correlate pre- and post-treatment plasma levels of basic fibroblast growth factor with response and progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks for up to 3 years from study entry.