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

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.

• Authors: C Bolling, T Graefe, C Lübbing, F Jankevicius, S Uktveris, A Cesas, W-H Meyer-Moldenhauer, H Starkmann, M Weigel, K Burk, A-R Hanauske
• Journal: Investigational new drugs (Invest New Drugs) Vol. 24 Issue 6 Pg. 521-7 (Nov 2006) ISSN: 0167-6997 [Print] United States
• PMID: 16699974 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Serum Albumin
• methotrexate-serum albumin
• Cisplatin
• Methotrexate

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Transitional Cell (drug therapy, pathology, secondary)
• Cisplatin (administration & dosage)
• Female
• Humans
• Male
• Methotrexate (administration & dosage, adverse effects, blood)
• Middle Aged
• Serum Albumin (administration & dosage, adverse effects)
• Treatment Outcome
• Urinary Bladder Neoplasms (drug therapy, pathology)