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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00578149
First received: December 19, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

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.

Estimated Enrollment: 45
Study Start Date: May 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578149

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Aaron Allen, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00578149     History of Changes
Other Study ID Numbers: 05-415
Study First Received: December 19, 2007
Last Updated: December 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
chemoradiotherapy
Lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014