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

NCT00578149 | Completed Phase 2

• 1 other identifier: 05-415
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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).

Conditions

Non-Small Cell Lung Cancer

Keywords

chemoradiotherapy; Lung cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Bevacizumab DRUG

Carboplatin DRUG

Paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Aaron Allen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

US (2)