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: S K Williamson, M K Wolf, M A Eisenberger, M O'Rourke, W Brannon, E D Crawford
• Journal: Investigational new drugs (Invest New Drugs) Vol. 13 Issue 2 Pg. 167-70 ( 1995) ISSN: 0167-6997 [Print] United States
• PMID: 8617581 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antineoplastic Agents
• Depsipeptides
• Hormones
• Peptides, Cyclic
• didemnins
• Prostate-Specific Antigen

Topics

• Adenocarcinoma (drug therapy, mortality, secondary)
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Depsipeptides
• Drug Evaluation
• Drug Resistance, Neoplasm
• Heart (drug effects)
• Hormones (therapeutic use)
• Humans
• Infusions, Intravenous
• Longitudinal Studies
• Lung (drug effects)
• Male
• Peptides, Cyclic (administration & dosage, adverse effects, therapeutic use)
• Prostate-Specific Antigen (blood)
• Prostatic Neoplasms (drug therapy, mortality)