A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Carcinoma (NSCLC)
|Non-Small Cell Lung Cancer||Drug: Pemetrexed, Cisplatin, Bevacizumab||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy in Patients With Advanced Non-Squamous, Non-Small Cell Lung Carcinoma|
- Progression free survival [ Time Frame: 6 weeks ]
- Objective response rate [ Time Frame: 6 weeks ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Pemetrexed, Cisplatin, Bevacizumab
Chemotherapy infusion on Day 1 of a 3-week cycle
Drug: Pemetrexed, Cisplatin, Bevacizumab
The majority of patients with NSCLC present with inoperable locally advanced or metastatic disease for which no curative therapy is available. For these patients, platinum based doublet combination regimens have become standard of care due to increased survival rates over platinum therapy alone.
In order to try to improve on the overall survival, clinicians have attempted to add a third cytotoxic agent to their standard regimen(s). Although this approach demonstrated an improved objective response, no additional benefit was noted in overall survival.
Recent development and approval of new targeted chemotherapies during the past 10 years has prompted clinical trials to test the efficacy of newly FDA approved agents such as gefitinib, erlotinib, and bevacizumab in advanced NSCLC.
Although gefitinib and erlotinib have both demonstrated clinical activity in refractory NSCLC, neither agent improved clinical outcome when added to standard 1st line platinum based chemotherapy. In contrast, a recently completed randomized Phase 3 trial investigating the addition of bevacizumab to 1st line paclitaxel plus carboplatin chemotherapy reported a 23% improvement in the median overall survival for the paclitaxel/carboplatin plus bevacizumab treatment arm (12.5m vs. 10.2m; p=0.007). It is therefore appealing to study a cisplatin combination with bevacizumab to determine if there is any additive benefit. Pemetrexed is an ideal agent to use in combination with cisplatin since it is well tolerated and efficacy is comparable to other cisplatin combinations. Patients will receive a maximum of 6 cycles. Those who complete 1 cycle will be evaluated for toxicity; more than 1 cycle, response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998166
|United States, New York|
|North Shore University Hospital|
|Lake Success, New York, United States, 11042|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Mark Stoopler, MD||Columbia University|