A Trial for Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer
|Non Small Cell Lung Cancer||Drug: First-Line Treatment Drug: Maintenance Drug: Second-Line Treatment||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second Line Treatment of Stage IIIB or IV NSCLC|
- Progression-free survival of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV non-small cell lung cancer [ Time Frame: An expected average of 2 years ]
- Survival [ Time Frame: An expected average of 2 years ]
|Study Start Date:||December 2008|
|Study Completion Date:||September 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: First Line Treatment
All patients will receive first-line treatment in 21-day cycles for up to 6 cycles. All first-line medications are administered intravenously on Day 1 of each cycle. Response is assessed every 2 cycles until disease progression.
Drug: First-Line Treatment
Docetaxel 75 mg/m2, Carboplatin AUC=6,Bevacizumab 15 mg/kg administered in 21-day cycles on day 1 of each cycle.
Other Name: Avastin
Patients who have not progressed will continue on bevacizumab maintenance
Bevacizumab 15 mg/kg maintenance in 21 day cycles for up to 18 cycles.
Other Name: Avastin
Experimental: Second-Line Treatment
Upon disease progression, eligible patients will be randomized for second-line treatment to one of two treatment arms. All second line medications are administered intravenously on Day 1 of each 21 day cycle until disease progression. Response is assessed every 2 cycles.
Drug: Second-Line Treatment
Arm A: Pemetrexed 500 mg/m2 plus Bevacizumab 15 mg/kg administered in 21 day cycles on Day 1 of each cycle. Arm B: Pemetrexed 500 mg/m2 administered in 21 day cycles on Day 1 of each cycle.
This phase II trial will address the issues of bevacizumab treatment duration and treatment safety by incorporating bevacizumab into a variation of the ECOG reference regimen as first-line therapy for patients with non-squamous non-small cell lung cancer. Following disease progression or treatment failure, the potential benefit of continued bevacizumab therapy will be tested by randomizing patients to two treatment arms, including second-line chemotherapy with or without further bevacizumab.
For first-line treatment, a regimen of carboplatin, docetaxel, and bevacizumab followed by maintenance bevacizumab therapy will be given to all patients. Upon disease progression or treatment failure, patients will be randomized to one of two second-line regimens: pemetrexed plus bevacizumab or pemetrexed monotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735891
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Chandra P Belani, MD||Penn State College of Medicine|