Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Untreated Advanced Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Avastin, Alimta
Sponsored by
About this trial
This is an interventional treatment trial for Untreated Advanced Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: I am 18 years of age or older. I have advanced non-small lung cancer. I have not had any major surgical procedures within 28 days prior to my starting treatment. I have high blood pressure that is controlled. I am not on heparin, coumadin or lovonox for treatment of medical conditions. I do not have serious wound healing problems. I have not received any previous treatment, except radiation therapy for my disease. Exclusion Criteria: -
Sites / Locations
- The CINJ at Cooper University HospitalRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00254319
First Posted
November 14, 2005
Last Updated
November 14, 2005
Sponsor
The Cooper Health System
1. Study Identification
Unique Protocol Identification Number
NCT00254319
Brief Title
Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title
Phase II Trial of Bevacizumab (Avastin) Plus Pemetrexed (Alimta) and Carboplatin in Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Cooper Health System
4. Oversight
5. Study Description
Brief Summary
Avastin is a novel antiangiogenic agent that has recently been shown to improve response rates and survival of patients with advanced nonsquamous non-small cell lung cancer when added to front-line carboplatin/paclitaxel chemotherapy, and is now being routinely incorporated into the treatment of these patients. Alimta is a recently approved chemotherapeutic that has shown activity against non-small cell lung cancer when given alone and in combination with carboplatin, has a favorable toxicity profile andrequires only a brief (10 minute) infusion time. Therefore we propose to study the combination of Avasin, Alimta, and Carboplatin administered as front-line therapy to patients with advanced nonsquamous non-small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated Advanced Non-Small Cell 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
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Avastin, Alimta
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
I am 18 years of age or older. I have advanced non-small lung cancer. I have not had any major surgical procedures within 28 days prior to my starting treatment.
I have high blood pressure that is controlled. I am not on heparin, coumadin or lovonox for treatment of medical conditions. I do not have serious wound healing problems. I have not received any previous treatment, except radiation therapy for my disease.
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elta Field
Phone
856-325-6759
Email
field-elta@cooperhealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Stevenson, M.D.
Organizational Affiliation
The Cooper Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
The CINJ at Cooper University Hospital
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Stevenson, MD
First Name & Middle Initial & Last Name & Degree
Generosa Grana, MD
12. IPD Sharing Statement
Learn more about this trial
Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
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