Condition category
Cancer
Date applied
25/02/2007
Date assigned
14/03/2007
Last edited
04/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nong Xu

ORCID ID

Contact details

79 Qingchun Road
Hangzhou
310003
China
+86 571 56731277
xunong@medmail.com.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZJWST491010G20518

Study information

Scientific title

Acronym

Study hypothesis

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

The First Affiliated Hospital Ethical Review Board, School of Medicine, Zhejiang University. Approved on 10/12/2002. Ethics Review No. 26 (2002)

Study design

An open label, multi-centre, phase II study

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Gemcitabine, carboplatin

Primary outcome measures

1. Objective response rate
2. Tolerability

Secondary outcome measures

1. Overall survival
2. Progression-free survival

Overall trial start date

01/01/2003

Overall trial end date

15/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

39

Participant 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

Recruitment start date

01/01/2003

Recruitment end date

15/06/2006

Locations

Countries of recruitment

China

Trial participating centre

79 Qingchun Road
Hangzhou
310003
China

Sponsor information

Organisation

School of Medicine, Zhejiang University (China)

Sponsor details

338 Yuhangtang Road
Hangzhou
310058
China
+86 571 88208019
Chyx@zju.edu.cn

Sponsor type

University/education

Website

http://www.cmm.zju.edu.cn/english/

Funders

Funder type

Government

Funder name

Health Bureau of Zhejiang Province (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17559681

Publication citations

  1. Results

    Xu N, Zhang XC, Xiong JP, Fang WJ, Yu LF, Qian J, Zhang L, A phase II trial of gemcitabine plus carboplatin in advanced transitional cell carcinoma of the urothelium., BMC Cancer, 2007, 7, 98, doi: 10.1186/1471-2407-7-98.

Additional files

Editorial Notes