metastatic urothelial carcinoma patients after the failure in the cisplatin-based first line systemic chemotherapy
Conditions
Interventions
GD therapy: gemcitabine 800 mg/m2 administered by a 30 min intravenous infusion on days 1, and 8 and docetaxel 40 mg/m2 also by intravenous infusion on days 1 and 8
gemcitabine 1000 mg/m2 administered
Sponsors
Nagoya City University Graduate School of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients had histologically proven metastatic UC of the urinary bladder or upper urinary tract. All of the patients had received surgical treatment or been biopsied for the primary lesions. Also, all had one previous chemotherapy treatment that consisted of M-VAC, MEC, or GC. Previous chemotherapy was completed at least 4 weeks before enrollment. Patients were required to have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 2 or lower as per the World Health Organization criteria; adequate bone marrow reserve (white blood cell (WBC) count higher than 3,500, platelet count higher than 100,000, and hemoglobin higher than 10 g/dL) was required of all patients. Other requirements were: adequate hepatic function (serum bilirubin 1.5 mg/dl, or less), adequate renal function (serum creatinine 1.5 mg/dl, or measured creatinine clearance of at least 60 ml/min), and an estimated life expectancy of at least 12 weeks. Patients with non-malignant systemic disease that precluded them from receiving therapy, including active infection, any clinically significant cardiac arrhythmia, and/or congestive heart failure, were not eligible. Written informed consent was obtained from all of the patients before this clinical trial.
Exclusion criteria
Exclusion criteria: exclusion criteria patients were below: the patients who had allergy to gemcitabine, and , or taxane derivatives, or patients suspected interstitial lung disease by X ray, or patients who had past history of radiation theapy in chest, or patients suspected infection diseases, or patients who had the possibility of pregnancy, or patients who had uncontrolled cancer diffferent from urothelial cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event progression free survival objective response rate | — |
Countries
Japan
Contacts
Public ContactTaku Naiki
Nagoya City University Graduate School of Medical Sciences Department of Nephro-urology
Outcome results
None listed