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A Phase II Trial of Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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.

Inclusion Criteria:

- Histologically confirmed diagnosis of non-small cell lung carcinoma of non-squamous

- AJCC stage IIIB or Stage IV

- Measurable disease by RECIST criteria, and must have at least one target lesion 1cm
or greater in diameter for optimal perfusion CT scanning

- No prior chemotherapy treatment or VEGF inhibitor treatment, although prior treatment
with EGFR inhibitors will be allowed

- 18 years of age or older

- Adequate bone marrow, renal and liver function as outlined in the protocol

Exclusion Criteria:

- Life expectancy of less than 12 weeks

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study

- Inadequately controlled hypertension

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- NYHA Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to study

- History of stroke, transient ischemic attack within 6 months prior to study

- Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been
definitively treated with radiation and/or surgery. Note that patients with a history
of CNS metastases or cord compression are allowed if they have been definitively
treated and are clinically stable. Maintenance steroids are allowed. Two weeks need
to elapse from the completion of radiation, or 4 weeks from surgery, before starting
avastin. Patients do have to remain clinically asymptomatic.

- Significant vascular disease

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of need for major medical surgical
procedure during the course of the study

- Minor surgical procedure, excluding FNA, core biopsy or placement of a vascular
access device, within 7 days prior to study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

- Serious, non-healing wound, ulcer, or bone fracture

- Proteinuria at screening

- Pregnant or lactating

- Lung carcinoma of squamous cell histology

- History of hemoptysis within 3 months prior to study enrollment

- Current, on-going treatment with full-dose warfarin or its equivalent at the onset of

- Current or recent (within 10 days of enrollment) use of aspirin or chronic use of
other NSAIDs

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the 6-month progression free survival rate in the study population.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Rebecca Heist, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

April 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Abraxane
  • Carboplatin
  • Bevacizumab
  • Avastin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617