Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00323869|
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : July 27, 2016
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Non-small Cell Lung Cancer (NSCLC)||Drug: Bevacizumab Drug: Gemcitabine Drug: Carboplatin||Phase 2|
This is a open-label, phase 2, single-arm, multi-center study of bevacizumab combined with gemcitabine and carboplatin. This treatment is for newly-diagnosed advanced non-small cell lung cancer (NSCLC), excluding squamous cell carcinoma. All subjects will receive 15 mg/kg bevacizumab every 3 weeks cycle, 1000 mg/m² of gemcitabine on day 1 and 8 every 3 weeks cycle and carboplatin (AUC= 5 ) every 3 weeks. Carboplasm will be administered 1 hour prior to the gemcitabine infusion, bevacizumab will be administered 1 hour following chemotherapy infusion.
Subjects will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab may continue as long as patients have no evidence of progressive disease and no significant treatment-related toxicities.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma)|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Bevacizumab + carboplatin + gemcitabine
Bevacizumab in combination with carboplatin and gemcitabine:
•Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles.
Carboplatin was administered before the gemcitabine infusion:
•Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles
Bevacizumab was administered 1 hour after end of all chemotherapy infusions:
•Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity
Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
Other Names:Drug: Gemcitabine
Other Name: GemzarDrug: Carboplatin
- Progression-free Survival (PFS) [ Time Frame: 18 months ]Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.
- Response Rate (CR + PR + SD) [ Time Frame: 6 weeks ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE
Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.
- Complete Response (CR) = disappearance of all target lesions
- Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions
- Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions
- Stable Disease (SD): No significant effect, does not meet criteria for PR or PD.
- Overall Survival (OS) [ Time Frame: 36 months ]To evaluate the safety of the combination regimen.
- Partial Response (PR) [ Time Frame: 6 weeks ]Number of subjects with PR per RECIST criteria
- Complete Response (CR) [ Time Frame: 6 weeks ]Number of subjects with CR per RECIST criteria
- Stable Disease (SD) [ Time Frame: 6 weeks ]Number of subjects with SD per RECIST criteria
- Time-to-First Event [ Time Frame: 18 months ]Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation
- Overall Survival (OS) at 12 Months [ Time Frame: 12 months ]Number of subjects surviving 1 year after treatment initiation
- Overall Survival (OS) at 24 Months [ Time Frame: 24 months ]Number of subjects surviving 2 years after treatment initiation
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): NCT00323869
|United States, California|
|VA Palo Alto Healthcare System|
|Palo Alto, California, United States, 94304-1290|
|Santa Clara Valley Medical Center|
|San Jose, California, United States, 95128|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Heather A Wakelee, MD||Stanford University|