Phase II evaluation of paclitaxel by short intravenous infusion in metastatic melanoma
Autor: | Theresa Smith, Omar Eton, Julie A. Ellerhorst, Agop Y. Bedikian, Nicholas Papadopoulos, Carl Plager |
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Rok vydání: | 2004 |
Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Tumour regression Skin Neoplasms Maximum Tolerated Dose Paclitaxel Metastatic melanoma Phases of clinical research Angiogenesis Inhibitors Dermatology Gastroenterology chemistry.chemical_compound Internal medicine medicine Humans Melanoma Aged Response rate (survey) business.industry Choroid Neoplasms Liver Neoplasms Remission Induction Middle Aged medicine.disease Survival Rate Clinical trial Treatment Outcome Oncology chemistry Injections Intravenous Cancer cell Disease Progression Female business |
Zdroj: | Melanoma Research. :63-66 |
ISSN: | 0960-8931 |
DOI: | 10.1097/00008390-200402000-00010 |
Popis: | In four clinical trials in mostly chemotherapy-naive patients with metastatic melanoma, paclitaxel was found to be effective with a response rate of 16%. In vitro studies have shown that following exposure of cancer cells to paclitaxel for 1 h, sensitivity to repeat paclitaxel doses decreased markedly at 48-72 h and returned at 120 h. In this phase II study we assessed the efficacy of paclitaxel at a dose of 90 mg/m per day given intravenously over 80 min on days 1, 5 and 9 every 3 weeks, initially in two groups of 14 patients with metastatic choroidal and non-choroidal melanoma. One patient in the non-choroidal melanoma group had a confirmed response, and 23 additional patients were therefore accrued to this group. (One patient withdrew consent for treatment within a week from start of therapy. The patient was considered to have received inadequate treatment and a replacement was registered.) A total of 52 patients with a median age of 55 years (range 21-79 years) were treated. Forty-four patients completed two or more courses of paclitaxel and were evaluable for response. We observed >50% tumour regression in six patients. All the responses except one were amongst the 32 evaluable patients with non-choroidal melanoma. The response rate in this group was 15.6%. During the 219 courses of paclitaxel delivered, the side effects were mild, manageable and mostly reversible. No grade 3 acute allergic reactions were observed. Paclitaxel given by short intravenous infusion is marginally active against previously treated non-choroidal melanoma. |
Databáze: | OpenAIRE |
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