Status:
COMPLETED
Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Pulmonary Diseases
Neoplasms, Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA). Primary objective: * To determin...
Detailed Description
The study included : * A screening phase up to 21 days followed by registration * Treatment initiation within 5 working days of registration * A treatment phase with 14-day study treatment cycles unt...
Eligibility Criteria
Inclusion
- Participants who met the following criteria were eligible for the study.
- 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
- 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
- The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00284141
Start Date
January 1 2006
End Date
July 1 2008
Last Update
December 10 2012
Active Locations (3)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Laval, Canada
3
Sanofi-Aventis Administrative Office
Paris, France