Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC Abraxane Carboplatin Bevacizumab Avastin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
The purpose of this research study is to learn more about whether the combination of drugs carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the standard treatments for advanced NSCLC is the combination of the drugs carboplatin, paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make the treatment difficult to tolerate. Some of these side effects are caused by the solution used to dissolve paclitaxel before it can be administered. Abraxane is a different form of paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to learn more about how the drug Avastin may work to treat cancer.

Detailed description:
* 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.

Arms:
arm 1: Carboplatin, nab-paclitaxel, and bevacizumab

Interventions: intervention 1: carboplatin intervention 2: Nab-paclitaxel intervention 3: Bevacizumab
Intervention descriptions: intervention 1: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles intervention 2: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles intervention 3: IV infusion

Protocol document: