A Phase II Trial of Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
- Participants will receive a single dose of Avastin 2 weeks before they are scheduled to
start the combination of carboplatin, Abraxane and Avastin. Before the dose of Avastin
is given, a perfusion CT scan and blood work will be performed. The perfusion CT scan
and blood draw will be repeated 12 days after teh Avastin dose (2 days before beginning
study treatment).
- The combination of carboplatin, Abraxane and Avastin will be given in 3 week cycles and
all drugs will be given as infusions. On day 1, Avastin, Abraxane and carboplatin wil
be given. On Day 8 and 15, Abraxane will be given.
Participants can receive up to 6 cycles of carboplatin, Abraxane and Avastin if their
disease does not get worse and they do not experience intolerable side effects.
- The following assessment procedures will be performed on day 1 of each cycle: physical
exam; routine urine test (every other cycle); Performance status assessment. Routine
blood tests will be performed on days 1, 8 and 15.
- Additional procedures performed after cycles 2 and 4 and at 6 months after beginning
study treatment are as follows: CT scan, PET scan, perfusion CT and blood work.
- After 6 cycles of carboplatin, Abraxane and Avastin, participants will receive Avastin
alone for three weeks. Participants can continue to receive Avastin as long as they do
not experience unacceptable side effects.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the 6-month progression free survival rate in the study population.
3 years
No
Rebecca Heist, MD MPH
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
07-339
NCT00642759
April 2008
April 2014
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |