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Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer


- There are three phases of treatment 1)chemoradiation, 2) consolidation and
3)maintenance therapy.

- The chemoradiation phase is from week 1 to week 7. The following will occur during
this phase: Daily chest radiation starting on day 1; pre-medication for paclitaxel;
weekly intravenous administration of paclitaxel and carboplatin; intravenous
administration of bevacizumab once weekly every three weeks starting on day 1.

- During weeks 8-9, patients will undergo a PET/CT scan for restaging.

- The consolidation phase is from week 10 to week 16. The following will occur during
this phase: Pre-medication for paclitaxel; intravenous administration of paclitaxel and
carboplatin twice weekly every 3 weeks; intravenous administration of bevacizumab once
weekly every 3 weeks.

- The maintenance phase is from week 17 to week 52. The following will occur during this
phase; intravenous administration of bevacizumab once a week every three weeks for 1
year; PET/CT scan every three months.

- The following evaluations will occur during treatment: 1)Patients will be evaluated
weekly by the study doctor, 2) Weight, difficulty or discomfort in swallowing,
shortness of breath and over well-being will be recorded, 3) Weekly lab test will
include CBC, chemistries, and liver function tests. 4) Followed through each cycle of
chemotherapy and every 6-8 weeks for the duration of the study.

- The following evaluations will occur after treatment: 1)Every 6-8 weeks assessed for
response with a CT or PET/CT scan for one year, 2) Toxicity will also be assessed at
each follow-up interval.


Inclusion Criteria:



- Histologically confirmed non-small cell lung cancer (NSCLC) that have been evaluated
and determined not to be candidates for surgical resection as part of their
definitive management of stage III disease.

- Age 18 years or older

- ECOG performance status of 0-1

- Life Expectancy of greater than six months

- Normal organ and marrow function

- Women and men of child-bearing potential must agree to use adequate contraception

Exclusion Criteria:

- Prior chemotherapy or thoracic radiation therapy

- Squamous histology or any histology in close proximity to a major vessel

- Active hemoptysis

- History of hypercoagulability

- Known distant metastatic disease

- History of allergic reactions attributed to compounds with similar chemical or
biological composition to bevacizumab, carboplatin, paclitaxel or other agents used
in this study

- Patients with uncontrolled intercurrent illness

- Pregnant women

- Major surgical procedure, open biopsy, or significant traumatic injury with in 28
days prior to day 0

- Minor surgical procedure within 7 days to day 0

- HIV-positive patients receiving combination anti-retroviral therapy.

- Non-skin cancer malignancy in the past 5 years.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.

Principal Investigator

Aaron Allen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

05-415

NCT ID:

NCT00578149

Start Date:

May 2006

Completion Date:

August 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • chemoradiotherapy
  • Lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617