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


CONCLUSIONS
The combination of MTX-HSA with cisplatin is feasible and shows antitumor activity against urothelial carcinomas combined with an acceptable toxicity profile.
Bolling
C
C
Medizinische Abteilung, AK St. Georg, Lohmühlenstrasse 5, Hamburg 20099, Germany. Studiensekretariat.Medizin1@ak-st.georg.lbk-hh.de
Graefe
T
T
Lübbing
C
C
Jankevicius
F
F
Uktveris
S
S
Cesas
A
A
Meyer-Moldenhauer
W-H
WH
Starkmann
H
H
Weigel
M
M
Burk
K
K
Hanauske
A-R
AR
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D008875:Middle Aged; D012709:Serum Albumin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
D012709:Serum Albumin; C040811:methotrexate-serum albumin; D002945:Cisplatin; D008727:Methotrexate