Phase II trial of 9-aminocamptothecin administered as a 72-hour continuous infusion in metastatic colorectal carcinoma
| Autor: | James L. Abbruzzese, S Graham, Enrique Diaz-Canton, W P Ballard, Susan G. Arbuck, Richard Pazdur, Rodger J. Winn, J E Bradof |
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| Rok vydání: | 1997 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Colorectal cancer medicine.medical_treatment Antineoplastic Agents Adenocarcinoma Drug Administration Schedule Metastasis Internal medicine Carcinoma medicine Humans Infusions Intravenous Infusion Pumps Aged Chemotherapy Performance status business.industry Cancer Middle Aged medicine.disease Surgery Irinotecan Camptothecin Female Aminocamptothecin business Colorectal Neoplasms medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 15(8) |
| ISSN: | 0732-183X |
| Popis: | PURPOSE The camptothecin derivative irinotecan has demonstrated clinical activity in metastatic colorectal carcinoma in both chemotherapy-naive and fluorouracil-refractory patients. 9-Aminocamptothecin (9-AC; NSC 603071), another camptothecin derivative, was selected for clinical development based on preclinical activity, including cures in human tumor xenografts resistant to standard anticancer agents. We report a phase II trial of 9-AC in patients with previously untreated metastatic colorectal carcinoma. PATIENTS AND METHODS Colorectal cancer patients with measurable disease, a performance status of 0 to 2 (Zubrod), and no prior chemotherapy for metastatic disease received 9-AC. A cycle of therapy was 35 microg/m2/h for 72 consecutive hours (840 microg/m2/d for 3 days) and rest on days 4 to 14; a course of therapy was defined as two cycles (28 days). Patients were assessed for response after two courses. RESULTS Seventeen patients with metastatic colorectal cancer were entered onto this trial. No complete or partial responses were noted. Treatment was well tolerated; toxic effects consisted mainly of neutropenia, nausea, vomiting, stomatitis, fatigue, and anemia. Grade 3 to 4 toxicity was limited to neutropenia (grade 3 in four patients and grade 4 in six), anemia (grade 3 in two patients), and vomiting (grade 3 in two patients). No grade 3 or 4 diarrhea occurred. Only two patients had their 9-AC dose reduced to 30 microg/m2/h. The median nadir absolute granulocyte count (AGC) was 1,500/microL. The median number of courses given was two and the median time to disease progression was 8 weeks. CONCLUSION At the dose and schedule used in this trial, 9-AC lacked antitumor activity in metastatic colorectal cancer. 9-AC infusion schedules of longer duration are currently being investigated in this disease. |
| Databáze: | OpenAIRE |
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