Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000370505
Ethics application status
Approved
Date submitted
17/12/2003
Date registered
17/12/2003
Date last updated
17/12/2003
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of intravenous vinorelbine and oral capecitabine in patients with advanced breast cancer
Scientific title
Phase II study of intravenous Vinorelbine (Navelbine) and Capecitabine (Xeloda) in patients with advanced breast cancer, assessing efficacy and toxicity
Secondary ID [1] 34 0
National Clinical Trials Registry: NCTR440
Universal Trial Number (UTN)
Trial acronym
NavXel, BC-03-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 35 0
Condition category
Condition code
Cancer 42 42 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous vinorelbine 25 mg/m2 day 1 and 8 and oral capecitabine 1000 mg/m2 days 1-14 every 21 days. Maximum 9 cycles.
Intervention code [1] 1239 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 71 0
Primary endpoint is efficacy.
Timepoint [1] 71 0
Assessed by measuring response (tumour shrinkage) every 3 cycles using Response Evaluation Criteria in Solid Tumors (RECIST) criteria up to maximum of 9 cycles.
Secondary outcome [1] 130 0
Toxicity
Timepoint [1] 130 0
Each cycle, up to max 9 cycles.
Secondary outcome [2] 131 0
Time to progression
Timepoint [2] 131 0
Every 3 months off treatment until progression/ death or loss to followup.
Secondary outcome [3] 132 0
Duration of response
Timepoint [3] 132 0
Every 3 months until progression/ death or loss to followup.
Secondary outcome [4] 133 0
Overall survival
Timepoint [4] 133 0
Every 3 months off treatment until death or loss to followup.

Eligibility
Key inclusion criteria
Advanced/ metastatic breast cancer; maximum of 1 prior chemotherapy for metastatic cancer; at lteat `1 measurable lesion by RECIST; > 18 years; KPS > 80%; adequate organ function
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Life expectance <12 weeks; significant comorbidities; peripheral neuropathy > grade1; other invasive cancers; unable to swallow pills whole

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
13/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 58 0
Commercial sector/Industry
Name [1] 58 0
Roche Australia
Country [1] 58 0
Australia
Funding source category [2] 59 0
Commercial sector/Industry
Name [2] 59 0
Pierre Fabre Australia/France
Country [2] 59 0
Primary sponsor type
Individual
Name
Dr. Alison Davis, Dr Stephen Ackland
Address
Country
Secondary sponsor category [1] 43 0
Individual
Name [1] 43 0
Dr Craig Lewis
Address [1] 43 0
Country [1] 43 0
Secondary sponsor category [2] 44 0
Individual
Name [2] 44 0
Dr Francis Parnis
Address [2] 44 0
Country [2] 44 0
Secondary sponsor category [3] 45 0
Individual
Name [3] 45 0
Dr Eugene Moylan
Address [3] 45 0
Country [3] 45 0
Secondary sponsor category [4] 46 0
Commercial sector/Industry
Name [4] 46 0
Roche and Pierre Fabre
Address [4] 46 0
Country [4] 46 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 369 0
The Canberra Hospital
Ethics committee address [1] 369 0
Ethics committee country [1] 369 0
Australia
Date submitted for ethics approval [1] 369 0
Approval date [1] 369 0
Ethics approval number [1] 369 0
Ethics committee name [2] 370 0
Calvary Hospital
Ethics committee address [2] 370 0
Ethics committee country [2] 370 0
Australia
Date submitted for ethics approval [2] 370 0
Approval date [2] 370 0
Ethics approval number [2] 370 0
Ethics committee name [3] 371 0
Liverpool Hospital
Ethics committee address [3] 371 0
Ethics committee country [3] 371 0
Australia
Date submitted for ethics approval [3] 371 0
Approval date [3] 371 0
Ethics approval number [3] 371 0
Ethics committee name [4] 372 0
The Prince of Wales Hospital
Ethics committee address [4] 372 0
Ethics committee country [4] 372 0
Australia
Date submitted for ethics approval [4] 372 0
Approval date [4] 372 0
Ethics approval number [4] 372 0
Ethics committee name [5] 373 0
Newcastle Mater Miserichordiae Hospital
Ethics committee address [5] 373 0
Ethics committee country [5] 373 0
Australia
Date submitted for ethics approval [5] 373 0
Approval date [5] 373 0
Ethics approval number [5] 373 0
Ethics committee name [6] 374 0
Ashford Cancer Centre
Ethics committee address [6] 374 0
Ethics committee country [6] 374 0
Australia
Date submitted for ethics approval [6] 374 0
Approval date [6] 374 0
Ethics approval number [6] 374 0

Summary
Brief summary
This trial will determine the safety and activity of giving two new drugs together in women with advanced breast cancer. Both of these drugs are active when given alone; giving them together may be better.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36298 0
Address 36298 0
Country 36298 0
Phone 36298 0
Fax 36298 0
Email 36298 0
Contact person for public queries
Name 10428 0
Dr Alison Davis,
Address 10428 0
Medical Oncology Unit
The Canberra Hospital
PO Box 11
Woden ACT 2606
Country 10428 0
Australia
Phone 10428 0
(02) 6244 2220
Fax 10428 0
(02) 6244 4266
Email 10428 0
[email protected].
Contact person for scientific queries
Name 1356 0
Dr Alison Davis
Address 1356 0
Medical Oncology Unit
The Canberra Hospital
PO Box 11
Woden ACT 2606
Country 1356 0
Australia
Phone 1356 0
(02) 6244 2220
Fax 1356 0
(02) 6244 4266
Email 1356 0
[email protected].

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.