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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578149
• Other study ID #: 05-415
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2007
• Last updated: December 19, 2007
• Start date: May 2006
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bevacizumab

• Carboplatin

• Paclitaxel

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
Secondary	Response rate, overall survival, and patterns of failure and toxicity of the novel therapy.