Phase II study of MTX-HSA in combination with Cisplatin as first line treatment in patients with advanced or metastatic transitional cell carcinoma
| Autor: | S. Uktveris, K. Burk, H. Starkmann, A. Cesas, W.-H. Meyer-Moldenhauer, Feliksas Jankevičius, M. Weigel, C. Bolling, C. Lubbing, Axel-R. Hanauske, T. Graefe |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male musculoskeletal diseases Oncology medicine.medical_specialty Phases of clinical research Internal medicine Antineoplastic Combined Chemotherapy Protocols Carcinoma Humans Medicine heterocyclic compounds Pharmacology (medical) skin and connective tissue diseases Serum Albumin Aged Pharmacology Cisplatin Carcinoma Transitional Cell Metastatic Transitional Cell Carcinoma Bladder cancer business.industry Middle Aged medicine.disease Human serum albumin body regions Methotrexate Treatment Outcome Urinary Bladder Neoplasms Tolerability embryonic structures Female business medicine.drug |
| Zdroj: | Investigational New Drugs. 24:521-527 |
| ISSN: | 1573-0646 0167-6997 |
| Popis: | To assess the efficacy, tolerability and safety of MTX-HSA (methotrexate (MTX) covalently linked to human serum albumin (HSA)) combined with cisplatin as first line therapy for advanced bladder cancer.Patients (pat) were treated with a loading dose of 110 mg/m(2) of MTX-HSA followed by a weekly dose of 40 mg/m(2) starting on day 8. Cisplatin was given on day 2 of each 28 day cycle at a dose of 75 mg/m(2).Tumor response evaluation was possible in 7 patients. Complete response (CR) and partial response (PR) was observed in 1 patient each (overall response rate: 29%). Key toxicities included CTC Grade (G) 3/4 stomatitis in 6 patients, vomiting G3 in 1 patient, fatigue G3 in 1 patient and thrombocytopenia G3 in 3 patients.The combination of MTX-HSA with cisplatin is feasible and shows antitumor activity against urothelial carcinomas combined with an acceptable toxicity profile. |
| Databáze: | OpenAIRE |
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