A phase II trial of gemcitabine plus carboplatin in advanced transitional cell carcinoma of the urothelium

Completed

• Conditions: Cancer; Advanced transitional cell carcinoma of the urothelium

• Registration Number: ISRCTN88259320
• Lead Sponsor: School of Medicine, Zhejiang University (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

1. Patients with locally advanced or metastatic transitional cell carcinoma of the bladder, ureter or renal pelvis were eligible for this study
2. Patients were required to have histologically or cytologically proven locally advanced or metastatic transitional cell carcinoma of the bladder, ureter or renal pelvis
3. Prior cytotoxic treatment either in the adjuvant setting or for metastatic disease was permitted if the treatment had been completed at least six months prior to enrollment in the study
4. Prior radiotherapy was permitted but must have been completed at least six weeks prior to enrollment
5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
6. A life expectancy at least 3 months
7. Age between 18 and 75 years
8. Adequate bone marrow: absolute neutrophil count more than or equal to 1.5 x 10^9/L, platelet count more than or equal to 100 x 10^9/L, and hemoglobin more than or equal to 100 g/L
9. Adequate hepatic functions: aspartate aminotransferase/alanine aminotransferase, AST/ALT less than or equal to 3.0 times the Upper Normal Limit (UNL) and serum bilirubin less than or equal to 1.5 x UNL
10. Adequate renal functions: serum creatinine less than or equal to 1.5 x UNL and creatinine clearance more than or equal to 30 ml/min based on the Calvert formula
11. Adequate normal cardiac function

Exclusion Criteria

1. Second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma
2. Central nervous system (CNS) involvement
3. Prior radiotherapy in parameter lesions
4. Concurrent uncontrolled medical illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified