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A multicenter phase II study of the cryptophycin analog LY355703 in patients with platinum-resistant ovarian cancer.

Abstract
LY355703 is a synthetic product structurally related to the cryptophycin family isolated from the blue-green algae, which exerts a potent destabilization of microtubules during mitosis. This study was performed to determine the activity of LY355703 in patients with platinum-resistant advanced ovarian cancer and to characterize its toxicity profile. Twenty-six patients were enrolled in this study. Resistant disease was defined as a platinum-free interval of <6 months from primary treatment or rechallenge. LY355703 (1.5 mg/m(2)) was administered intravenously on days 1 and 8, every 3 weeks, infused over 2 h. From 24 patients evaluable for response, three partial responses (12.5%) and seven disease stabilizations were registered (29.2%), for an overall clinical benefit of 41.7%. Fourteen patients (58.3%) experienced a progression of the disease during treatment. Among the 25 patients evaluable for toxicity, two episodes of grade 3 anemia (8%); one, grade 3 thrombocytopenia (4%); one, grade 4 elevation of creatinine (4%); and one, grade 3 hyperbilirubinemia (4%) were reported. LY355703 has a modest activity in patients with platinum-resistant advanced ovarian cancer. Nevertheless, the considerable rate of disease stabilization in the absence of serious adverse events in this poor-prognosis study population suggests that this novel cryptophycin may deserve further investigation in this setting.
AuthorsG D'Agostino, J del Campo, B Mellado, M A Izquierdo, T Minarik, L Cirri, L Marini, J L Perez-Gracia, G Scambia
JournalInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society (Int J Gynecol Cancer) 2006 Jan-Feb Vol. 16 Issue 1 Pg. 71-6 ISSN: 1048-891X [Print] England
PMID16445613 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Depsipeptides
  • Lactams
  • Lactones
  • Platinum
  • cryptophycin 52
Topics
  • Adult
  • Aged
  • Depsipeptides (administration & dosage)
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Infusions, Intravenous
  • Lactams (administration & dosage)
  • Lactones (administration & dosage)
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Invasiveness (pathology)
  • Neoplasm Staging
  • Ovarian Neoplasms (drug therapy, mortality, pathology)
  • Platinum (therapeutic use)
  • Prognosis
  • Risk Assessment
  • Single-Blind Method
  • Survival Analysis
  • Treatment Outcome

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