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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Carboplatin
Paclitaxel
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring chemoradiotherapy, Lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response rate, overall survival, and patterns of failure and toxicity of the novel therapy.

Full Information

First Posted
December 19, 2007
Last Updated
December 19, 2007
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00578149
Brief Title
Bevacizumab and Carboplatin/Paclitaxel and Radiation in Non-Small Cell Lung Cancer
Official Title
Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
chemoradiotherapy, Lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
Secondary Outcome Measure Information:
Title
Response rate, overall survival, and patterns of failure and toxicity of the novel therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Allen, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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