A phase II trial of gemcitabine plus carboplatin in advanced transitional cell carcinoma of the urothelium
| ISRCTN | ISRCTN88259320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88259320 |
| Protocol serial number | ZJWST491010G20518 |
| Sponsor | School of Medicine, Zhejiang University (China) |
| Funder | Health Bureau of Zhejiang Province (China) |
- Submission date
- 25/02/2007
- Registration date
- 14/03/2007
- Last edited
- 04/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nong Xu
Scientific
Scientific
79 Qingchun Road
Hangzhou
310003
China
| Phone | +86 571 56731277 |
|---|---|
| xunong@medmail.com.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | An open label, multi-centre, phase II study |
| Secondary study design | Multi-centre |
| Scientific title | |
| Study objectives | Recent studies have demonstrated the effectiveness of cisplatin-based combinations in patients with advanced Transitional Cell Carcinoma (TCC) of the urothelium. Concern over cisplatin toxicity instigated a search for alternative regimens. The aim of the study was to evaluate the activity and tolerability of gemcitabine plus carboplatin combination as first-line treatment in patients with advanced transitional cell carcinoma of the urothelium. |
| Ethics approval(s) | The First Affiliated Hospital Ethical Review Board, School of Medicine, Zhejiang University. Approved on 10/12/2002. Ethics Review No. 26 (2002) |
| Health condition(s) or problem(s) studied | Advanced transitional cell carcinoma of the urothelium |
| Intervention | Patients with advanced TCC were treated with gemcitabine 1200 mg/m2 on days 1 and 8 and carboplatin area under the concentration-time curve (AUC) 5 on day 1 every 21 days. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Gemcitabine, carboplatin |
| Primary outcome measure(s) |
1. Objective response rate |
| Key secondary outcome measure(s) |
1. Overall survival |
| Completion date | 15/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 39 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 15/06/2006 |
Locations
Countries of recruitment
- China
Study participating centre
79 Qingchun Road
Hangzhou
310003
China
310003
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 09/06/2007 | Yes | No |
