Carboplatin, methotrexate, and vinblastine in the treatment of patients with advanced urothelial cancer. A phase II trial.
BACKGROUND
A Phase II study with carboplatin, methotrexate, and vinblastine (CAMV) was conducted with patients who had advanced urothelial cancer to investigate the activity and toxicity of carboplatin when used in combination chemotherapy.


METHODS
Thirty-six patients with advanced urothelial cancer were treated with carboplatin 300 mg/m2 (day 1), methotrexate 40 mg/m2 (days 1 and 8) and vinblastine 4 mg/m2 (days 1 and 8) every 4 weeks. Characteristics of the patients were as follows: men:women, 32:4; median age, 65 years (range, 42-76 years); and median Eastern Cooperative Oncology Group performance status, 0 (range, 0-2). Thirty-six patients were evaluable for toxicity and 33 for response.


RESULTS
Objective responses (OR) were achieved in 13 patients: 2 were complete responses (CR) (6%) and 11 were partial responses (33.4%). Median duration of OR was 7 months (range, 3-27 months). Median duration of CR was 10 months (range, 4-27 months), and median survival time for patients achieving complete response was 30.5 months (range, 28-33 months). Patients with a pretreatment creatinine clearance greater than or equal to 50 ml/minute showed a higher response rate: 48% OR and 10% CR. Toxicity was evaluated (World Health Organization criteria) on 164 cycles and was generally mild.


CONCLUSIONS
CAMV is an active and safe regimen in patients with advanced urothelial cancer, even in those with impaired renal function. It is recommended that future studies with this regimen be performed with pharmacokinetic modulation of carboplatin to improve the drug's tolerability and therapeutic activity.
Boccardo
F
F
Department of Medical Oncology 2, National Institute for Cancer Research, Genoa, Italy.
Pace
M
M
Guarneri
D
D
Canobbio
L
L
Curotto
A
A
Martorana
G
G
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000556:secondary; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D003404:Creatinine / Q000652:urine; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy / Q000473:pathology; D007682:Kidney Pelvis / Q000473:pathology; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D012074:Remission Induction; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage* / Q000009:adverse effects
D014747:Vinblastine; D003404:Creatinine; D016190:Carboplatin; D008727:Methotrexate