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Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Biomarker/Laboratory analysis, Treatment Completed 18 and over Pharmaceutical / Industry ARD6122
AVE0005, NCT00327171

Trial Description

Summary

The primary objective is to compare the objective response rate of AVE0005 (VEGF Trap) 4.0 mg/kg and 2.0 mg/kg intravenous (IV) every 2 weeks with historical control in patients with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin.

The secondary objectives are to further assess efficacy, safety, pharmacokinetics, immunogenicity, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life.

Eligibility Criteria

Inclusion Criteria:

Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma.

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

Platinum-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance

Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance

Evidence of at least one unidimensional measurable tumor lesion by computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) that has not been treated with surgery or radiation therapy

Exclusion Criteria:

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

Prior treatment with a vascular endothelial growth factor (VEGF) or VEGF receptor inhibitor

More than 3 chemotherapy regimens in the advanced disease treatment setting

Uncontrolled hypertension

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 NCT00327171
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.