Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer who are light or never smokers.
|Lung Cancer||Biological: bevacizumab Drug: carboplatin Drug: erlotinib hydrochloride Drug: pemetrexed disodium||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase II Trial of Carboplatin, Pemetrexed, and Bevacizumab Followed By Pemetrexed and Bevacizumab Maintenance Therapy in Patients With a Light or Never Smoking History|
- Progression-free Survival [ Time Frame: 1400 days ]Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. criteria each year, until subject death
- Overall Survival [ Time Frame: 1400 days ]Time of enrollment to date of death.
- Subjects Experiencing Toxicity [ Time Frame: 90 days ]Toxicity will be evaluated using CTCAE criteria, version 3, all grade 3 and 4 events.
|Study Start Date:||March 2010|
|Study Completion Date:||July 20, 2016|
|Primary Completion Date:||May 24, 2016 (Final data collection date for primary outcome measure)|
Single Arm Trial
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
15 mg/kg once per 21 day cycle (up to 4 cycles).
Other Name: AvastinDrug: carboplatin
Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
Other Name: ParaplatinDrug: erlotinib hydrochloride
150mg, daily for 21 day cycle (up to 4 cycles)
Other Name: TarcevaDrug: pemetrexed disodium
500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
Other Name: ALIMTA
- To estimate the progression-free survival (PFS) of patients with advanced non-small cell lung cancer who are never or light smokers treated with carboplatin, pemetrexed disodium, and bevacizumab followed by pemetrexed disodium and bevacizumab maintenance therapy.
- To estimate the overall survival (OS) of patients treated with this regimen.
- To estimate the toxicity of treatment using the NCI CTCAE version 3.0.
- To conduct an exploratory analysis of molecular markers, e.g., Kirsten rat sarcoma (KRAS) and epidermal growth factor receptor (EGFR) mutations, in patients with a never or light smoking history and to analyze any potential association with response, PFS, and OS.
- To assess response to second-line erlotinib hydrochloride therapy according to RECIST criteria.
OUTLINE: This is a multicenter study.
- First-line therapy: Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve partial or complete response or have stable disease progress to maintenance therapy.
- Maintenance therapy: Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who experience disease progression or unacceptable toxicity may receive second-line therapy with erlotinib hydrochloride as part of standard-of-care treatment.
Tissue samples are collected at baseline for laboratory biomarker analysis.
After completion of maintenance therapy, patients are followed every 4 weeks for 2 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344824
|United States, North Carolina|
|Asheville, North Carolina, United States, 28801|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|CCHC New Bern Cancer Care|
|New Bern, North Carolina, United States, 28562|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Thomas E. Stinchcombe, MD||Duke University|