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.
Conclusion: 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.