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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