Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000001695
Ethics application status
Approved
Date submitted
6/07/2005
Date registered
7/07/2005
Date last updated
16/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II trial of gemcitabine in a fixed dose rate infusion combined with cisplatin in patients with operable biliary tract carcinomas
Scientific title
A phase II trial of gemcitabine in a fixed dose rate infusion combined with cisplatin in patients with operable biliary tract carcinomas with the primary objective tumour response
Secondary ID [1] 84 0
National Clinical Trials Registry: NCTR570
Universal Trial Number (UTN)
Trial acronym
ABC trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenocarcinoma of the gallbladder or intra/extrahepatic bile ducts 63 0
Condition category
Condition code
Cancer 74 74 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gemcitabine delivered as fixed dose-rate infusion with cisplatin
Intervention code [1] 1 0
Treatment: Drugs
Comparator / control treatment
Single arm trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 107 0
Objective tumour response.
Timepoint [1] 107 0
Measured every 6 weeks during study treatment, and post treatment.
Secondary outcome [1] 232 0
Tolerability and safety of treatment
Timepoint [1] 232 0
Prior to each cycle of treatment, and at end of treatment
Secondary outcome [2] 233 0
Duration of response
Timepoint [2] 233 0
Prior to starting every second treatment cycle, then 6 monthly for 12 months, then as clinically indicated
Secondary outcome [3] 234 0
Time to treatment failure
Timepoint [3] 234 0
Assessed at end of treatment
Secondary outcome [4] 235 0
Time to disease progression
Timepoint [4] 235 0
Prior to starting every second treatment cycle, then 6 monthly for 12 months, then as clinically indicated
Secondary outcome [5] 236 0
Response rate using CA19-9
Timepoint [5] 236 0
Before every treatment cycle, then 6 weekly until disease progression or 12 months, whicever occurs first
Secondary outcome [6] 237 0
Overall survival
Timepoint [6] 237 0
6 weekly until death

Eligibility
Key inclusion criteria
Histologic or cytologic diagnosis of adenocarcinogen of the gallbladder or intra/extrahepatic bile ducts with locally advanced or metastatic disease that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy. Measurable disease.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,TAS

Funding & Sponsors
Funding source category [1] 104 0
Commercial sector/Industry
Name [1] 104 0
Eli Lilly Australia
Country [1] 104 0
Australia
Primary sponsor type
Other Collaborative groups
Name
AGITG/ NHMRC Clinical Trials Centre
Address
92-94 Parramatta Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 80 0
None
Name [1] 80 0
nil
Address [1] 80 0
Country [1] 80 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 812 0
Prince of Wales Hospital Border Medical Oncology
Ethics committee address [1] 812 0
Ethics committee country [1] 812 0
Australia
Date submitted for ethics approval [1] 812 0
Approval date [1] 812 0
Ethics approval number [1] 812 0
Ethics committee name [2] 813 0
Austin Health
Ethics committee address [2] 813 0
Ethics committee country [2] 813 0
Australia
Date submitted for ethics approval [2] 813 0
Approval date [2] 813 0
Ethics approval number [2] 813 0
Ethics committee name [3] 814 0
St Vincent's Hospital- Melbourne
Ethics committee address [3] 814 0
Ethics committee country [3] 814 0
Australia
Date submitted for ethics approval [3] 814 0
Approval date [3] 814 0
Ethics approval number [3] 814 0
Ethics committee name [4] 815 0
Newcastle Mater Hospital
Ethics committee address [4] 815 0
Ethics committee country [4] 815 0
Australia
Date submitted for ethics approval [4] 815 0
Approval date [4] 815 0
Ethics approval number [4] 815 0
Ethics committee name [5] 816 0
Nepean Hospital
Ethics committee address [5] 816 0
Ethics committee country [5] 816 0
Australia
Date submitted for ethics approval [5] 816 0
Approval date [5] 816 0
Ethics approval number [5] 816 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35961 0
Address 35961 0
Country 35961 0
Phone 35961 0
Fax 35961 0
Email 35961 0
Contact person for public queries
Name 9190 0
Burcu Cakir
Address 9190 0
NHMRC Clinical Trials Centre
Locked Bag 88
Camperdown NSW 2050
Country 9190 0
Australia
Phone 9190 0
+61 2 95625000
Fax 9190 0
+61 2 95651863
Email 9190 0
GoldsteinD@SESAHS.NSW.GOV.AU
Contact person for scientific queries
Name 118 0
Associate Professor David Goldstein
Address 118 0
Prince of Wales Hospital
High Street
Randwick NSW 2031
Country 118 0
Australia
Phone 118 0
+61 2 93822577
Fax 118 0
Email 118 0
GoldsteinD@SESAHS.NSW.GOV.AU

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.