Phase II trial of perillyl alcohol in patients with metastatic colorectal cancer.
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.
Meadows
Sherry Morgan
SM
Department of Medicine, Division of Medical Oncology, The University of Wisconsin, Madison, WI, USA. slm@medicine.wisc.edu
Mulkerin
Daniel
D
Berlin
Jordan
J
Bailey
Howard
H
Kolesar
Jill
J
Warren
Deb
D
Thomas
James P
JP
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
D000970:Antineoplastic Agents; D039821:Monoterpenes; C032208:perillyl alcohol