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Cited by 293

The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index.

Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

Heymach, John V., Johnson, Bruce E., Prager, Diane, Csada, Edit, Roubec, Jaromír, Pešek, Miloš, Špásová, Irena, Belani, Chandra P., Bodrogi, István, Gadgeel, Shirish, Kennedy, Sarah J., Hou, Jeannie, Herbst, Roy S.·2007·Journal of Clinical Oncology
DOI 10.1200/jco.2006.10.5122
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Abstract

Purpose: Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor-2 and epidermal growth factor receptor kinase activity. The activity of vandetanib plus docetaxel was assessed in patients with previously treated non–small-cell lung cancer (NSCLC). Patients and Methods: This two-part study comprised an open-label run-in phase and a double-blind randomized phase. Eligible patients had locally advanced or metastatic (stage IIIB/IV) NSCLC after failure of first-line platinum-based chemotherapy. The primary objective of the randomized phase was to prolong progression-free survival (PFS) in patients receiving vandetanib (100 or 300 mg/d) plus docetaxel (75 mg/m 2 intravenous infusion every 21 days) versus placebo plus docetaxel. The study was designed to have more than 75% power to detect 50% prolongation at a one-sided significance level of P < .20. Secondary objectives included objective response rate, overall survival, safety and tolerability. Results: In the randomized phase (n = 127), median PFS was 18.7 weeks for vandetanib 100 mg plus docetaxel (n = 42; hazard ratio v docetaxel = 0.64; one-sided P = .037); 17.0 weeks for vandetanib 300 mg plus docetaxel (n = 44; hazard ratio v docetaxel = 0.83; one-sided P = .231); and 12 weeks for docetaxel (n = 41). There was no statistically significant difference in overall survival among the three treatment arms. Common adverse events included diarrhea, rash, and asymptomatic prolongation of corrected QT (QT C) interval. Conclusion: The primary objective was achieved, with vandetanib 100 mg plus docetaxel demonstrating a significant prolongation of PFS compared with docetaxel in relation to the prespecified significance level. On the basis of these encouraging data, phase III evaluation of vandetanib 100 mg plus docetaxel in second-line NSCLC has been initiated.

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Metadata

Authors
Heymach, J. V., Johnson, B. E., Prager, D., Csada, E., Roubec, J., Pešek, M., Špásová, I., Belani, C. P., Bodrogi, I., Gadgeel, S., Kennedy, S. J., Hou, J., & Herbst, R. S.
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2007-09-20
Volume
25
Issue
27
Pages
4270-4277
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2006.10.5122
OpenAlex
W2127809030
Cited by
293
References
30
FWCI
34.63
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer. https://app.cochat.ai/papers/10.1200/jco.2006.10.5122
The paper
Heymach, J. V., Johnson, B. E., Prager, D., Csada, E., Roubec, J., Pešek, M., Špásová, I., Belani, C. P., Bodrogi, I., Gadgeel, S., Kennedy, S. J., Hou, J., & Herbst, R. S. (2007). Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2006.10.5122

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.