Phase II study of i.v. CI-980 in patients with advanced platinum refractory epithelial ovarian carcinoma
| Autor: | Creighton L. Edwards, Claire F. Verschraegen, John J. Kavanagh, Christina A. Meyers, Annette Hasenburg, Charles A. Conrad, Axel Grothey, Andrzej P. Kudelka, Datla G. Varma, William Grove, Arthur D. Forman, Ralph S. Freedman |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Organoplatinum Compounds Pyridines Population Phases of clinical research Antineoplastic Agents Gastroenterology Internal medicine medicine Humans Pharmacology (medical) Infusions Intravenous education Survival rate Aged Subclinical infection Ovarian Neoplasms Pharmacology education.field_of_study Dose-Response Relationship Drug business.industry Carcinoma Middle Aged medicine.disease Mitotic inhibitor Survival Rate Dyspnea Treatment Outcome Drug Resistance Neoplasm Pyrazines Toxicity Female Carbamates Phlebitis Ovarian cancer business Agranulocytosis Hyponatremia Truncal ataxia |
| Zdroj: | Anti-Cancer Drugs. 9:405-409 |
| ISSN: | 0959-4973 |
| DOI: | 10.1097/00001813-199806000-00006 |
| Popis: | CI-980 is a synthetic mitotic inhibitor that binds to tubulin at the colchicine site, inhibiting the polymerization of microtubules and arresting cellular division in metaphase. Myelosuppression and neurotoxicity were dose-limiting in phase I studies. Sixteen patients with stage III and IV platinum-refractory ovarian cancer received 4.5 mg/m2/day of CI-980 as a continuous i.v. infusion for 72 h, repeated every 3 weeks. Eleven patients had progression and four patients had stable disease. One patient (6%; 95% CI 0-25%) achieved a partial response after 9 months of treatment which lasted for 27 months. The overall median survival was 7 months. Grade 4 granulocytopenia occurred in five patients, with two episodes of neutropenic fever. Neurological toxicity was mild with 12 episodes of transient subclinical recent memory loss documented in four patients by specialized neuropsychological evaluations. One patient each had hallucinations and mild truncal ataxia, and four patients had mild, reversible neurosensory toxicity. One episode of severe hypoxemia and dyspnea occurred in a patient with chronic obstructive pulmonary disease. CI-980 has minimal activity and is tolerable in a population of heavily pretreated patients with platinum refractory ovarian cancer. |
| Databáze: | OpenAIRE |
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