Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC
Part of paid clinical trials in Waterbury, Connecticut.
- Sponsor
- Accelerated Community Oncology Research Network
- Study ID
- NCT00517595
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pemetrexed and Gemcitabine plus Bevacizumab — DRUGBevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m\^2 and gemcitabine 1500 mg/m\^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.
Study Details
The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden.
Key Dates
- First listed
- Aug 17, 2007
- Start date
- Aug 31, 2007
- Status verified
- Mar 2012
- Primary completion
- Apr 30, 2011
- Completion
- Apr 30, 2011
Study Design
- Enrollment
- 48 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months. ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical Oncology & Hematology | Waterbury | Connecticut | 06708 | - |
| Augusta Oncology Associates | Augusta | Georgia | 30901 | - |
| Central Georgia Cancer Care | Macon | Georgia | 31201 | - |
| Northwest Georgia Oncology Center | Marietta | Georgia | 30060 | - |
| Hematology Oncology Centers of the Northern Rockies | Billings | Montana | 59101 | - |
| Tri-County Oncology Hematology Associates | Canton | Ohio | 44718 | - |
| Pacific Oncology, PC | Portland | Oregon | 97225 | - |
| Pennsylvania Oncology Hematology Associates | Philadelphia | Pennsylvania | 19106 | - |
| The West Clinic | Memphis | Tennessee | 38120 | - |
| Cancer Specialists of Tidewater | Chesapeake | Virginia | 23320 | - |
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