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

Untreated Advanced Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00254319
• Other study ID #: AVF3158'S
• Status: Recruiting
• Phase: Phase 2
• First received: November 14, 2005
• Last updated: November 14, 2005

Study information

• Verified date: November 2005
• Source: The Cooper Health System
• Contact: Elta Field
• Phone: 856-325-6759
• Email: field-elta[@]cooperhealth.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Untreated Advanced Non-Small Cell Lung Cancer

Intervention

Drug:
• Avastin, Alimta

Locations

Country	Name	City	State
United States	The CINJ at Cooper University Hospital	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States,