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Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-Small-Cell-Lung Adenocarcinoma

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed 18 and over Pharmaceutical / Industry ARD6123
AVE0005B/2001, NCT00284141

Trial Description

Summary

Primary:

To determine the overall objective response rate (ORR) of AVE0005 (VEGF Trap) 4.0 mg/kg intravenously (IV) every 2 weeks in patients with platinum- and erlotinib-resistant, locally advanced or metastatic non-small cell lung adenocarcinoma (NSCLA).

Secondary:

To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this patient population

To evaluate the safety profile of IV AVE0005 (VEGF Trap).

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed non-small-cell lung adenocarcinoma that is locally advanced or metastatic

Prior treatment with at least 2 cancer drug regimens in the advanced disease setting

Platinum- and erlotinib-resistant disease defined by relapse or progression during or after treatment

Measurable disease by RECIST criteria

ECOG Performance status less than or equal to 2

Resolution of any toxic effects of prior therapy

Adequate organ and bone marrow function

Female patients must be post-menopausal, surgically sterile or using effective contraception

Willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

Diagnosis of squamous-cell lung cancer or any second malignancy within the last 5 years (except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri)

Prior treatment with a VEGF or VEGF receptor inhibitor with the exception of bevacizumab (Avastin-TM)

Anticipation of a need for major surgical procedure

Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, or cytokine therapy) of study enrollment

Uncontrolled hypertension

Any severe or acute medical or psychiatric problem within the past 6 months requiring further investigation or that may cause undue risk for the patient's safety

History of brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease

Active infection or on antiretroviral therapy for HIV disease

Pregnant or breast-feeding

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis - US - Bridgewater

Regeneron Pharmaceuticals

ICD CSD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00284141
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.