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Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by The Cooper Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Cooper Health System
ClinicalTrials.gov Identifier:
NCT00254319
First received: November 14, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Untreated Advanced Non-Small Cell Lung Cancer
 Drug: Avastin, Alimta
 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: Phase II Trial of Bevacizumab (Avastin) Plus Pemetrexed (Alimta) and Carboplatin in Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by The Cooper Health System:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254319

Contacts
Contact: Elta Field 856-325-6759 field-elta@cooperhealth.edu

Locations
United States, New Jersey
The CINJ at Cooper University Hospital Recruiting
Voorhees, New Jersey, United States, 08043
Principal Investigator: James Stevenson, MD            
Sub-Investigator: Generosa Grana, MD            
Sponsors and Collaborators
The Cooper Health System
Investigators
Principal Investigator: James Stevenson, M.D. Cooper University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00254319     History of Changes
Other Study ID Numbers: AVF3158'S
Study First Received: November 14, 2005
Last Updated: November 14, 2005
Health Authority: United States: Food and Drug Administration

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
Pemetrexed
Bevacizumab
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013