title: Phase II study of MGI-114 administered intravenously for 5 days every 28 days to patients with metastatic colorectal cancer.
abstract: We examined the use of MGI-114 (6-hydroxymethyacylfulvene) for the treatment of patients with advanced colorectal carcinoma. Twenty-six patients were enrolled, with a median age of 60 years (range 41-75); 64% were male and all patients had a performance status of 0 or 1. We administered a dose of 11 mg/m2/d x 5 days every 4 weeks. With a median of two cycles (range 0-6) administered, no complete responses or partial responses were observed. Four patients had no change in disease (16%); 15 patients (57%) had progressive disease; seven patients were inevaluable (27%). Toxicity was evaluated in 25 of 26 patients. The main toxicities were hematologic, including granulocytopenia and thrombocytopenia. Neuropsychiatric adverse events included hallucination (7.7%), depression/anxiety (15.4%), and/or insomnia (19.2%). Given the lack of antitumor activity, further study of MGI-114 in colorectal cancer does not appear warranted.
authors.affiliation: Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Sunita Dwivedy
authors.initials: SD
authors.lastname: Nasta
authors.forename: Paulo M
authors.initials: PM
authors.lastname: Hoff
authors.forename: Christopher S
authors.initials: CS
authors.lastname: George
authors.forename: Marcus
authors.initials: M
authors.lastname: Neubauer
authors.forename: Steven C
authors.initials: SC
authors.lastname: Cohen
authors.forename: James
authors.initials: J
authors.lastname: Abbruzzese
authors.forename: Rodger
authors.initials: R
authors.lastname: Winn
authors.forename: Richard M
authors.initials: RM
authors.lastname: Pazdur
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012717:Sesquiterpenes / Q000008:administration & dosage / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D018906:Antineoplastic Agents, Alkylating; D012717:Sesquiterpenes; C102714:irofulven