title: Phase II evaluation of didemnin B in hormonally refractory metastatic prostate cancer. A Southwest Oncology Group study.
abstract: Didemnin B, a dipsipeptide isolated from the Caribbean tunicate Trididemnum with antitumor and antiviral activity was evaluated in a phase II trial in the treatment of metastatic, hormonally refractory adenocarcinoma of the prostate. Thirteen patients were treated with didemnin B at 3.5 mg/m2 and 20 patients were treated at 6.3 mg/m2 intravenously every 28 days. Response was assessed every 8 weeks. Of 32 evaluable patients there was one partial response for an overall response rate of 3% (95% confidence interval of 0.1-16%). The most common toxicities were nausea, vomiting, and diarrhea. Serious cardiac and pulmonary toxicities were also noted. This drug does not appear to warrant further evaluation in this disease as a single agent.
authors.affiliation: University of Kansas Medical Center, Kansas City, USA.
authors.forename: S K
authors.initials: SK
authors.lastname: Williamson
authors.forename: M K
authors.initials: MK
authors.lastname: Wolf
authors.forename: M A
authors.initials: MA
authors.lastname: Eisenberger
authors.forename: M
authors.initials: M
authors.lastname: O'Rourke
authors.forename: W
authors.initials: W
authors.lastname: Brannon
authors.forename: E D
authors.initials: ED
authors.lastname: Crawford
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047630:Depsipeptides; D004341:Drug Evaluation; D019008:Drug Resistance, Neoplasm; D006321:Heart / Q000187:drug effects; D006728:Hormones / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008137:Longitudinal Studies; D008168:Lung / Q000187:drug effects; D008297:Male; D010456:Peptides, Cyclic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000970:Antineoplastic Agents; D047630:Depsipeptides; D006728:Hormones; D010456:Peptides, Cyclic; C030051:didemnins; D017430:Prostate-Specific Antigen