Phase I/II study of intraperitoneal mitoxantrone in refractory ovarian cancer
| Autor: | R. Dubbelman, W.W. ten Bokkel Huinink, Amit M. Oza, O. Soepenberg, I.A.M. Mandjes, Aartsen Ej, J. G. McVie |
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| Rok vydání: | 1994 |
| Předmět: |
medicine.medical_specialty
medicine.drug_class Vomiting medicine.medical_treatment Phases of clinical research Peritonitis Gastroenterology Antimetabolite chemistry.chemical_compound Breast cancer Internal medicine medicine Humans Ovarian Neoplasms Chemotherapy Mitoxantrone business.industry Cancer Hematology Middle Aged medicine.disease Prognosis Hematologic Diseases Carboplatin Surgery Abdominal Pain Oncology chemistry Female Ovarian cancer business Injections Intraperitoneal medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 5(4) |
| ISSN: | 0923-7534 |
| Popis: | Summary Background Mitoxantrone has demonstrable clinical activity when administered intravenously in a wide range of malignancies. The feasibility and toxicity of intra-peritoneal administration was established in a phase I study. The optimal dose from the phase I was subsequently evaluated in a phase II study. Patients and methods 19 patients with refractory malignancies and extensive abdominal disease (13 ovarian cancer, 4 breast cancer, 2 mesothelioma) were entered in a phase I study. The dose of intraperitoneal mitoxantrone was escalated from 10 mg/m2, administered in 21 of fluid via a Tenkhoff catheter, to 55 mg/m2, in increments of 5 mg/m2. Cycles were repeated every three weeks. Sixty-seven cycles of mitoxantrone were administered, the maximum tolerable dose being 25 mg/m2. A phase II study at this dose was conducted in 14 patients with refractory ovarian cancer, all of whom had previously received systemic platinum based therapy. Five of the 14 had also previously been treated with intraperitoneal carboplatin. Fifty-one cycles were administered. Results The dose limiting toxicity in the phase I study was peritoneal irritation and pain. Leucopenia was frequent at doses equal or greater than 30 mg/m2. Three complete remissions were documented in the phase I study (2 breast cancer and 1 ovarian cancer). There was no significant haematological toxicity in the phase II assessment, though local toxicity precluded further therapy in 2 patients. No objective responses were seen in the phase II evaluation. Conclusions These studies demonstrate the feasibility of intra-peritoneal mitoxantrone therapy in patients with peritoneal disease, but do not support its routine use in ovarian cancer. |
| Databáze: | OpenAIRE |
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