title: Phase II trial of perillyl alcohol in patients with metastatic colorectal cancer.
abstract: OBJECTIVE
  This is a phase II study of perillyl alcohol in the treatment of patients with metastatic colorectal carcinoma. The primary endpoint is time to progression. Secondary objectives are to evaluate objective response rate and toxicity.
  
  
  METHODS
  Eligible patients had metastatic adenocarcinoma of the colon or rectum. Patients received perillyl alcohol orally at a dose of 1200 mg/m2. Dose escalation to 1,600 mg/m2 was allowed.
  
  
  RESULTS
  Twenty-seven patients were enrolled. The median time to progression was 1.8 months (range 1 to 3 mo). Four patients received less than one cycle and were not evaluable for response. Of the remaining 23, all had progressive disease. There were no complete or partial responses. Toxicity was relatively mild, with fatigue, nausea and anemia predominating. Three patients withdrew from therapy for toxicity (grade 3 belching, bloating; grade 2 nausea, fatigue, vomiting, anorexia and increase perspiration; grade 1 anorexia).
  
  
  CONCLUSIONS
  Despite preclinical evidence of anticancer activity, oral perillyl alcohol administered at this dose and formulation does not appear to have clinical antitumor activity when used for patients with advanced colorectal carcinoma.
authors.affiliation: Department of Medicine, Division of Medical Oncology, The University of Wisconsin, Madison, WI, USA. slm@medicine.wisc.edu
authors.forename: Sherry Morgan
authors.initials: SM
authors.lastname: Meadows
authors.forename: Daniel
authors.initials: D
authors.lastname: Mulkerin
authors.forename: Jordan
authors.initials: J
authors.lastname: Berlin
authors.forename: Howard
authors.initials: H
authors.lastname: Bailey
authors.forename: Jill
authors.initials: J
authors.lastname: Kolesar
authors.forename: Deb
authors.initials: D
authors.lastname: Warren
authors.forename: James P
authors.initials: JP
authors.lastname: Thomas
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D039821:Monoterpenes / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D039821:Monoterpenes; C032208:perillyl alcohol