Phase II study of MTX-HSA in combination with cisplatin as first line treatment in patients with advanced or metastatic transitional cell carcinoma

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 dos...

Full description

Saved in:
Bibliographic Details
Published in:Investigational new drugs 2006-11, Vol.24 (6), p.521-527
Main Authors: Bolling, C, Graefe, T, Lübbing, C, Jankevicius, F, Uktveris, S, Cesas, A, Meyer-Moldenhauer, W-H, Starkmann, H, Weigel, M, Burk, K, Hanauske, A-R
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Bladder cancer
Cancer
Cancer therapies
Carcinoma, Transitional Cell - drug therapy
Carcinoma, Transitional Cell - pathology
Carcinoma, Transitional Cell - secondary
Cells
Cisplatin - administration & dosage
Clinical trials
Dihydrofolate reductase
Drug dosages
Drug therapy
Female
Humans
Male
Metastasis
Methotrexate - administration & dosage
Methotrexate - adverse effects
Methotrexate - blood
Middle Aged
Patients
Proteins
Serum Albumin - administration & dosage
Serum Albumin - adverse effects
Thrombocytopenia
Toxicity
Treatment Outcome
Tumors
Urinary Bladder Neoplasms - drug therapy
Urinary Bladder Neoplasms - pathology
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0167-6997
1573-0646
DOI:10.1007/s10637-006-8221-6