Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01107626|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2010
Last Update Posted : February 8, 2017
RATIONALE: 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. 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. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: bevacizumab Drug: pemetrexed disodium||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1282 participants|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 1, 2018|
U.S. FDA Resources
Experimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1
Experimental: Arm II
Patients receive pemetrexed IV over 10 minutes on days 1.
Drug: pemetrexed disodium
Experimental: Arm III
Patients receive bevacizumab as in arm I and pemetrexed as in arm II.
Given IVDrug: pemetrexed disodium
- Overall survival
- Progression-free survival
- Objective response as measured by RECIST
- Association between bevacizumab and pemetrexed disodium population pharmacokinetics
- Association between proteomic profiles and ICAM, VEGF, and FGF-beta with the clinical outcomes (Closed as of 04/01/2010)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107626
Show 434 Study Locations
|Principal Investigator:||Suresh Ramalingam, MD||Emory University|