Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer (NSCLC)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Progression-free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]To evaluate the safety of the combination regimen.
- Partial Response (PR) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Number of subjects with PR per RECIST criteria
- Complete Response (CR) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Number of subjects with CR per RECIST criteria
- Stable Disease (SD) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Number of subjects with SD per RECIST criteria
- Time-to-First Event [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Number of subjects surviving 1 year after treatment initiation
- Overall Survival (OS) at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]Number of subjects surviving 2 years after treatment initiation
|Study Start Date:||June 2006|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|