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Sub-category:
Ovarian Cancer
Category:
Gynecologic Cancer
Meeting:
2008 ASCO Annual Meeting
Session Type and Session Title:
Clinical Science Symposium, Targeted Therapies in Gynecologic Cancers
Abstract No:
5501
Citation:
J Clin Oncol 26: 2008 (May 20 suppl; abstr 5501)
Author(s):
U. A. Matulonis, S. T. Berlin, C. N. Krasner, K. Tyburski, J. Lee, M. Roche, S. P. Ivy, C. Lenahan, M. King, R. T. Penson
Abstract:
Background: Angiogenesis is important for ovarian cancer growth; blocking angiogenesis can lead to ovarian cancer regression. Cediranib (AZD2171) is a highly selective and potent oral tyrosine kinase inhibitor (TKI) of VEGFR1, VEGFR2, VEGFR3, and c-Kit. Methods: CTEP-sponsored phase II study of single agent Cediranib for recurrent ovarian, peritoneal, or tubal cancer. Eligibility: up to 2 prior lines of chemotherapy for recurrence, ECOG PS of 0 or 1, and normal organ function. Primary endpoint is response rate measured either by RECIST or modified GCIG CA125 criteria; other endpoints are PFS, toxicity, and pharmacodynamic endpoints. Results: 29 patients (pts) have been enrolled thus far; 27 are evaluable. 1 pt never started. 24 pts have ovarian cancer; 5 with peritoneal cancer. Of the 28 pts receiving drug, 12 pts had plat-sensitive and 16 had plat-resistant cancer. Starting phase II dose was 45 mg PO, but because of toxicities seen in the first 11 pts, the dose was lowered to 30 mg for subsequent pts. Thus far, grade 3 toxicities include: HTN (n=13; 5 pts on 45 mg and 8 pts on 30 mg), fatigue (n=5), diarrhea (n=3), vomiting (n=2), hyponatremia (n=2), oral cavity pain (n=2), and nausea, constipation, abdominal pain, headache, and hypothyroidism (all n=1). Gr 4 toxicities include: CNS hemorrhage (1 pt., 45 mg dose), lipase (1 pt) and hypertriglyceridemia (1 pt). No cardiac toxicities, bowel perforations, fistulas have been reported. Grade 1 or 2 abnormalities of thyroid function tests were reported in 10 pts and responded to thyroxine replacement therapy. 2 pts had grade 1 thyrotoxicosis. Tumor responses: 5 pts have had confirmed PR's (2 pts with plat-sens and 3 plat-resis) lasting 8, 11, 11, 12, and 25 weeks (overall RR of 18.5%), and 3 SD lasting 30, 27+, and 24 weeks. Of the remaining 19 pts, 2 pts had 28% decrease (lasting <16 weeks) and 27% decrease in disease after 2 cycles, 1 too early, 9 were removed for toxicities, and 7 had PD. Conclusions: Cediranib is an active drug in recurrent ovarian cancer; cediranib has predictable toxicities observed with other TKI's and warrants further study.
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by U. A. Matulonis :
Presentations by U. A. Matulonis :
Educational Book Manuscripts by U. A. Matulonis :
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