Lower Dose Chemotherapy Given More Frequent With Avastin to Treat Advanced Non-Squamous Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00655850|
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : May 24, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Paclitaxel Drug: Gemcitabine Biological: Avastin||Phase 2|
This is a non-randomized, open-label, pilot Phase II study of metronomic chemotherapy plus Avastin in chemo naïve subjects with advanced non-squamous, non-small cell carcinoma of the lung. The primary endpoint of this study is to assess the overall progression-free survival.
Subjects will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks, and Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated every 8 weeks.
Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will then continue until disease progression, intolerable toxicity or withdrawal of consent.
Potential biologic parameters to monitor anti-tumor activity of metronomic chemotherapy will be evaluated in 10 subjects. These biomarkers include: sequential determination of blood levels of VEGF, VEGFR2, thrombospondin-1, E-selectin, ICAM-1, and circulating endothelial cells and endothelial precursor cells.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Phase II Study of Metronomic Chemotherapy in Combination With Avastin in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer|
|Study Start Date :||March 2008|
|Primary Completion Date :||September 2015|
|Study Completion Date :||September 2016|
Experimental: Paclitaxel and Gemcitabine + Avastin
Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
Paclitaxel Dose Levels:
Other Name: TaxolDrug: Gemcitabine
Gemcitabine Dose Levels:
Other Name: GemzarBiological: Avastin
Other Name: Anti-VEGF
- Progression-Free Survival (PFS) [ Time Frame: Baseline to 24 months ]Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0). The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
- Number of Participants With Adverse Events [ Time Frame: Baseline through duration of treatment an average of 1 year ]All adverse events will be recorded as to the grade and relationship to the study drug in accordance with the Common Terminology Criteria for Adverse Events (CTCAE v 3.0)
- Overall Survival (OS) [ Time Frame: Baseline up to 84 months ]Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences death or lost to follow up.
- Objective Response Rate [ Time Frame: Baseline up to 12 months ]The percentage of patients who achieve a complete response and partial response according to RECIST criteria (v1.0).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655850
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294 - 0104|
|Principal Investigator:||Francisco Robert, M.D.||University of Alabama at Birmingham|