Phase II trial of perillyl alcohol in patients with metastatic colorectal cancer. Int J Gastrointest Cancer 2002;32(2-3):125-8
Date
06/10/2003Pubmed ID
12794248DOI
10.1385/IJGC:32:2-3:125Scopus ID
2-s2.0-0038308362 (requires institutional sign-in at Scopus site) 61 CitationsAbstract
PURPOSE: 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.
PATIENTS AND 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).
DISCUSSION: 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.
Author List
Meadows SM, Mulkerin D, Berlin J, Bailey H, Kolesar J, Warren D, Thomas JPAuthor
James P. Thomas MD, PhD Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Administration, OralAdult
Aged
Antineoplastic Agents
Colorectal Neoplasms
Disease Progression
Dose-Response Relationship, Drug
Female
Humans
Male
Middle Aged
Monoterpenes
Neoplasm Metastasis
Treatment Outcome
