Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer|
- Progression Free Survival(PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.
- Median Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.
- Best Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)
|Study Start Date:||September 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab, Docetaxel, and Gemcitabine
Treatment repeats every 21 days for up to 6 courses.
15 mg/kg on day 1 of a 21-day cycle
Other Name: bevacizumabDrug: docetaxel
75 mg/m2 on day 1
Other Name: docetaxelDrug: gemcitabine hydrochloride
900 mg/m2 on days 1, and 8,
Other Name: gemcitabine hydrochloride
- Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride.
- Evaluate the median time to progression in patients treated with this regimen.
- Estimate the response rate in patients treated with this regimen.
- Determine the median overall survival of patients treated with this regimen.
- Determine the incidence of adverse events associated with this regimen in these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.
After completion of study treatment, patients are followed up every 3 months.
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Fairview Hospital, Moll Pavilion|
|Cleveland, Ohio, United States, 44111|
|Hillcrest Hospital, a Cleveland Clinic Hospital|
|Mayfield Heights, Ohio, United States, 44124|
|Principal Investigator:||Nathan Pennell, MD, PhD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Principal Investigator:||Afshin Dowlati, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|