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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Paclitaxel

Drug: Carboplatin

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00578149

05-415

Details and patient eligibility

About

This study is being done to learn what effects (good and bad) bevacizumab in conjunction with carboplatin/paclitaxel and radiation therapy has on patients with non-small cell lung cancer (NSCLC).

Full description

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.