The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.
Phase I Safety and Pharmacokinetic Study of Recombinant Human Anti-Vascular Endothelial Growth Factor in Patients With Advanced Cancer
Abstract
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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Cites
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Use of an anti-IgE humanized monoclonal antibody in ragweed-induced allergic rhinitis☆☆☆★★★
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Cited by
Yang, J. C., Haworth, L., Sherry, R. M., Hwu, P., Schwartzentruber, D. J., Topalian, S. L., Steinberg, S. M., Chen, H. X., & Rosenberg, S. A. (2003) · New England Journal of Medicine · doi:10.1056/nejmoa021491 · Cited by 2,697
Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer
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Giantonio, B. J., Catalano, P. J., Meropol, N. J., O'Dwyer, P. J., Mitchell, E. P., Alberts, S. R., Schwartz, M. A., & Benson, A. B. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.09.6305 · Cited by 2,279
Miller, K. D., Chap, L. I., Holmes, F. A., Cobleigh, M. A., Marcom, P. K., Fehrenbacher, L., Dickler, M., Overmoyer, B. A., Reimann, J. D., Sing, A. P., et al. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.05.098 · Cited by 1,306
Dose Escalation Methods in Phase I Cancer Clinical Trials
Le Tourneau, C., Lee, J. J., & Siu, L. L. (2009) · JNCI: Journal of the National Cancer Institute · doi:10.1093/jnci/djp079 · Cited by 867
Metadata
- Authors
- Gordon, M. S., Margolin, K., Talpaz, M., Sledge, G. W., Holmgren, E., Benjamin, R., Stalter, S., Shak, S., & Adelman, D. C.
- Venue
- Journal of Clinical Oncology
- Published
- 2001-02-01
- Volume
- 19
- Issue
- 3
- Pages
- 843-850
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2145224595
- Cited by
- 913
- References
- 20
- FWCI
- 14.22
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Phase I Safety and Pharmacokinetic Study of Recombinant Human Anti-Vascular Endothelial Growth Factor in Patients With Advanced Cancer. https://app.cochat.ai/papers/10.1200/jco.2001.19.3.843
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- Gordon, M. S., Margolin, K., Talpaz, M., Sledge, G. W., Holmgren, E., Benjamin, R., Stalter, S., Shak, S., & Adelman, D. C. (2001). Phase I Safety and Pharmacokinetic Study of Recombinant Human Anti-Vascular Endothelial Growth Factor in Patients With Advanced Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2001.19.3.843
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