Phase II study of dolastatin-10 in patients with hormone-refractory metastatic prostate adenocarcinoma

Uika Vaishampayan, Michael Glode, Wei Du, Andrew Kraft, Gary Hudes, Jeremy Wright, Maha Hussain

Research output: Contribution to journalArticlepeer-review

157 Scopus citations


Dolastatin-10 is a natural, cytotoxic peptide with microtubule-inhibitory and apoptotic effects. It has demonstrated in vitro and in vivo efficacy in the DU-145 human prostate cancer model. A Phase II clinical trial was designed in patients with hormone-refractory prostate cancer. Dolastatin-10 was administered at a dose of 400 μg/m2 i.v. every 3 weeks. Dose escalation to 450 μg/m2 was permitted. Toxicity evaluation was conducted every 2 weeks, and assessment of response was done at the end of every two cycles. Sixteen patients were enrolled between October 1998 to December 1999. The median age was 71 years (range, 59-79 years). Median prostate-specific antigen value was 108 ng/ml (range, 15.3-1672 ng/ml). Of the 15 eligible patients, 7 were Caucasian and 8 were African-American. Eight patients had bone-only metastases, and seven had measurable disease with or without bone metastases. A total of 56 cycles have been administered. Only 2 patients required dose adjustment because of toxicity, and in 5 patients, dose escalation was feasible to 450 μg/m2. The major toxicities observed were grade 3 and 4 neutropenia in 8 patients and grade 3 neuropathy in 1 patient. All 15 patients are evaluable for response. Three patients demonstrated stable disease; 2 of these had bone disease, and 1 had nodal metastasis. All others had disease progression. Dolastatin-10 is very well tolerated in this elderly, pretreated population but lacks significant clinical activity as a single agent.

Original languageEnglish (US)
Pages (from-to)4205-4208
Number of pages4
JournalClinical Cancer Research
Issue number11
StatePublished - 2000

ASJC Scopus subject areas

  • General Medicine


Dive into the research topics of 'Phase II study of dolastatin-10 in patients with hormone-refractory metastatic prostate adenocarcinoma'. Together they form a unique fingerprint.

Cite this