title: High-dose methotrexate and 5-fluorouracil in patients with advanced colorectal carcinoma. A randomized study of two pretreatment intervals.
abstract: Thirty-two patients with untreated advanced colorectal carcinoma received high-dose methotrexate pretreatment followed sequentially by 5-fluorouracil (5-FU). Patients were randomized to receive high-dose methotrexate pretreatment at one of two intervals (0 h or 3 h before 5-FU). There were 16 patients in each study arm. The median methotrexate dose was 1,000 mg/m2 (range, 600-1,200 mg/m2) and that of 5-FU was 1,000 mg/m2 (range, 800-1,200 mg/m2). Treatments were repeated every 21 days. Three patients achieved partial remission (1 in the 3-h interval arm and 2 in the 0-h interval arm). As the response rate using this regimen was noted to be 9% with a less than 5% chance of achieving a response rate higher than 20%, we terminated this study although the therapy resulted in mild-to-moderate but infrequent toxicity. We thus conclude that pretreatment with high-dose methotrexate given at short intervals followed by 5-FU has no significant activity against colorectal carcinoma.
authors.affiliation: Department of Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston 77030.
authors.forename: J A
authors.initials: JA
authors.lastname: Ajani
authors.forename: M D
authors.initials: MD
authors.lastname: Kanojia
authors.forename: A Y
authors.initials: AY
authors.lastname: Bedikian
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001769:Blood / Q000187:drug effects; D002986:Clinical Trials as Topic; D015179:Colorectal Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D011897:Random Allocation; D012074:Remission Induction; D013997:Time Factors
chemical_list: D005472:Fluorouracil; D008727:Methotrexate