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Invest New Drugs. 2006 Nov;24(6):521-7.

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

Author information

1
Medizinische Abteilung, AK St. Georg, Lohmühlenstrasse 5, Hamburg 20099, Germany. Studiensekretariat.Medizin1@ak-st.georg.lbk-hh.de

Abstract

PURPOSE:

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.

METHODS:

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).

RESULTS:

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.

CONCLUSION:

The combination of MTX-HSA with cisplatin is feasible and shows antitumor activity against urothelial carcinomas combined with an acceptable toxicity profile.

PMID:
16699974
DOI:
10.1007/s10637-006-8221-6
[Indexed for MEDLINE]

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