Phase II trial of 10-Edam in patients with advanced colorectal carcinoma Journal Article


Authors: Kemeny, N.; Israel, K.; O'Hehir, M.
Article Title: Phase II trial of 10-Edam in patients with advanced colorectal carcinoma
Abstract: 10-Edam (10-ethyl-10-deaza-aminopterin), an antifolate derivative, was administered to 14 chemotherapy-naive patients with advanced colorectal carcinoma. The drug was given weekly by intravenous route at an initial dose of 80 mg/m2, with escalation or attenuation according to tolerance. Mucositis was dose limiting and occurred in 11 of 14 patients (78.6%). Removal from the study was required in one patient due to progressive pulmonary fibrosis that was histologically identical to methotrexate-induced lung damage. Toxicity was otherwise mild to moderate and included diarrhea, constipation, abdominal discomfort, anorexia, nausea/vomiting, rash, and fatigue. There were no responses to 10-Edam in this study, 95% confidence interval (0-0.23). Stable disease was achieved in four patients; the remaining 10 patients demonstrated progression within 9 weeks of initiating systemic therapy. 10-Edam employed at this dosage and schedule was not effective as a treatment against advanced colorectal carcinoma.
Keywords: clinical article; advanced cancer; phase 2 clinical trial; mucosa inflammation; age; colorectal carcinoma; lung fibrosis; intravenous drug administration; edatrexate; human; male; female; article
Journal Title: American Journal of Clinical Oncology
Volume: 13
Issue: 1
ISSN: 0277-3732
Publisher: Lippincott Williams & Wilkins  
Date Published: 1990-02-01
Start Page: 42
End Page: 44
Language: English
DOI: 10.1097/00000421-199002000-00012
PUBMED: 2305719
PROVIDER: scopus
DOI/URL:
Notes: Article -- Source: Scopus
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  1. Nancy Kemeny
    544 Kemeny
  2. Maureen A O'Hehir
    3 Ohehir