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dc.contributor.authorKarlan, B.-
dc.contributor.authorOza, A.-
dc.contributor.authorRichardson, G.-
dc.contributor.authorProvencher, D.-
dc.contributor.authorHansen, V.-
dc.contributor.authorBuck, M.-
dc.contributor.authorChambers, S.-
dc.contributor.authorGhatage, P.-
dc.contributor.authorPippitt Jr, C.-
dc.contributor.authorBrown III, J.-
dc.contributor.authorCovens, A.-
dc.contributor.authorNagarkar, R.-
dc.contributor.authorDavy, M.-
dc.contributor.authorLeath III, C.-
dc.contributor.authorNguyen, H.-
dc.contributor.authorStepan, D.-
dc.contributor.authorWeinreich, D.-
dc.contributor.authorTassoudji, M.-
dc.contributor.authorSun, Y.-
dc.contributor.authorVergote, I.-
dc.identifier.citationJournal of Clinical Oncology, 2012; 30(4):362-371-
dc.description.abstract<h4>Purpose</h4>To estimate the efficacy and toxicity of AMG 386, an investigational peptide-Fc fusion protein that neutralizes the interaction between the Tie2 receptor and angiopoietin-1/2, plus weekly paclitaxel in patients with recurrent ovarian cancer.<h4>Patients and methods</h4>Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomly assigned 1:1:1 to receive paclitaxel (80 mg/m(2) once weekly [QW], 3 weeks on/1 week off) plus intravenous AMG 386 10 mg/kg QW (arm A), AMG 386 3 mg/kg QW (arm B), or placebo QW (arm C). The primary end point was progression-free survival (PFS). Secondary end points included overall survival, objective response, CA-125 response, safety, and pharmacokinetics.<h4>Results</h4>One hundred sixty-one patients were randomly assigned. Median PFS was 7.2 months (95% CI, 5.3 to 8.1 months) in arm A, 5.7 months (95% CI, 4.6 to 8.0 months) in arm B, and 4.6 months (95% CI, 1.9 to 6.7 months) in arm C. The hazard ratio for arms A and B combined versus arm C was 0.76 (95% CI, 0.52 to 1.12; P = .165). Further analyses suggested an exploratory dose-response effect for PFS across arms (Tarone's test, P = .037). Objective response rates for arms A, B, and C were 37%, 19%, and 27%, respectively. The incidence of grade ≥ 3 adverse events (AEs) in arms A, B, and C was 65%, 55%, and 64%, respectively. Frequent AEs included hypertension (8%, 6%, and 5% in arms A, B, and C, respectively), peripheral edema (71%, 51%, and 22% in arms A, B, and C, respectively), and hypokalemia (21%, 15%, and 5% in arms A, B, and C, respectively). AMG 386 exhibited linear pharmacokinetic properties at the tested doses.<h4>Conclusion</h4>AMG 386 combined with weekly paclitaxel was tolerable, with a manageable and distinct toxicity profile. The data suggest evidence of antitumor activity and a dose-response effect, warranting further studies in ovarian cancer.-
dc.description.statementofresponsibilityBeth Y. Karlan, Amit M. Oza, Gary E. Richardson, Diane M. Provencher, Vincent L. Hansen, Martin Buck, Setsuko K. Chambers, Prafull Ghatage, Charles H. Pippitt Jr, John V. Brown III, Allan Covens, Raj V. Nagarkar, Margaret Davy, Charles A. Leath III, Hoa Nguyen, Daniel E. Stepan, David M. Weinreich, Marjan Tassoudji, Yu-Nien Sun and Ignace B. Vergote-
dc.publisherAmer Soc Clinical Oncology-
dc.rights© 2011 by American Society of Clinical Oncology-
dc.subjectPeritoneal Neoplasms-
dc.subjectOvarian Neoplasms-
dc.subjectFallopian Tube Neoplasms-
dc.subjectNeoplasm Recurrence, Local-
dc.subjectRecombinant Fusion Proteins-
dc.subjectAntineoplastic Combined Chemotherapy Protocols-
dc.subjectDisease-Free Survival-
dc.subjectSurvival Analysis-
dc.subjectDouble-Blind Method-
dc.subjectAged, 80 and over-
dc.subjectMiddle Aged-
dc.titleRandomized, double-blind, placebo-controlled phase II study of AMG 386 combined with weekly paclitaxel in patients with recurrent ovarian cancer-
dc.typeJournal article-
Appears in Collections:Aurora harvest 4
Obstetrics and Gynaecology publications

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