Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)

Abstract

BACKGROUNDChemotherapy options for the patients with advanced urothelial carcinoma and renal dysfunction are limited. The authors performed a Phase II trial of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction.METHODSForty‐two patients were accrued; 37 eligible patients were treated. Patients received paclitaxel 225 mg/m2 over three hours followed by carboplatin targeted area under the concentration‐time curve = 6 mg/mL · minute every three weeks for up to six cycles.RESULTSThe median number of cycles received was four (range, one to six). The objective response rate was 24.3% (95% confidence interval, 11.9–41.7%). The median progression free survival was 3 months and the median overall survival was 7.1 months. The number of poor prognostic risk factors (Eastern Cooperative Oncology Group performance status > 1 or lung, liver, or bone metastases) significantly predicted for survival. The most common ≥ 1 Grade 3 toxicities included granulocytopenia (60%) and neurotoxicity (35%).CONCLUSIONSPaclitaxel/carboplatin is a chemotherapy option for patients with advanced urothelial carcinoma and renal dysfunction. Future trials in chemotherapy development for this patient population are warranted. Cancer 2002;95:1022–7. © 2002 American Cancer Society.DOI 10.1002/cncr.10782

Treatment of elderly patients with advanced urological cancer

“…Other combinations with paclitaxel, oxaliplatin or epirubicin have shown some effectivity in small phase II trials [39][40][41].…”

Adjuvant chemotherapy for transitional cell carcinoma of the bladder: Paradigms for the design of clinical trials

“…Several phase II trials have shown that newer drugs, such as paclitaxel and docetaxel, have potential as single agents or in combination in the treatment of metastatic urethelial cancer [30][31][32][33]. Carboplatin has also been tested in patients with renal dysfunction [31,32].…”

The Role of Taxanes in the Management of Bladder Cancer

“…The dose of paclitaxel recommended for phase II study was 225 mg/m 2 . Subsequently, several phase II trials have been performed with varying doses of paclitaxel (150-225 mg/ m 2 ) and carboplatin (AUC 5-6) reporting overall response rates of 14%-65%, with complete responses in 0%-40% [16][17][18][19][20][21]. This regimen has proven well tolerated with predominantly mild hematologic and neurologic toxicities.…”