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Journal of Clinical Oncology, Vol 19, Issue 3 (February), 2001: 843-850
© 2001 American Society for Clinical Oncology

Phase I Safety and Pharmacokinetic Study of Recombinant Human Anti-Vascular Endothelial Growth Factor in Patients With Advanced Cancer

By M. S. Gordon, K. Margolin, M. Talpaz, G. W. Sledge, Jr, E. Holmgren, R. Benjamin, S. Stalter, S. Shak, D. C. Adelman

From the Indiana University School of Medicine, Indianapolis, IN; City of Hope National Medical Center, Duarte; Genentech, Inc, South San Francisco, CA; The University of Texas, M.D. Anderson Cancer Center, Houston, TX.

Address reprint requests to Michael S. Gordon, MD, Suite 415, 4001 N Third St, Phoenix, AZ 85012; email: msgordon{at}u.arizona.edu

PURPOSE: We investigated the safety and pharmacokinetics of a recombinant human monoclonal antibody to vascular endothelial growth factor (rhuMAb VEGF) in patients with cancer.

PATIENTS AND METHODS: Cohorts of patients with metastatic cancer having failed prior therapy entered a phase I trial of rhuMAb VEGF administered by a 90-minute intravenous infusion at doses from 0.1 to 10.0 mg/kg on days 0, 28, 35, and 42. Patients underwent pharmacokinetic sampling on day 0 and had serum samples obtained during the subsequent 28 days. Response assessment was carried out on days 49 and 72.

RESULTS: Twenty-five patients with a median Eastern Cooperative Oncology Group performance status of 0 were accrued. There were no grade III or IV adverse events definitely related to the antibody. There were three episodes of tumor-related bleeding. Infusions of rhuMAb VEGF were well tolerated without significant toxicity. Grades I and II adverse events possibly or probably related to study drug included asthenia, headache, and nausea. Pharmacokinetics revealed a linear profile with a half-life of 21 days. There were no objective responses, though 12 patients experienced stable disease over the duration of the study.

CONCLUSION: rhuMAb VEGF was safely administered without dose-limiting toxicity at doses ranging up to 10 mg/kg. Multiple doses of rhuMAb VEGF were well tolerated, and pharmacokinetic studies indicate that doses of >= 0.3 mg/kg have a half-life similar to that of other humanized antibodies. Subsequent trials will explore rhuMAb VEGF alone and in combination chemotherapy.




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