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
ACTRN12605000316606
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
6/09/2005
Date last updated
7/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase II study of Paclitaxel, and Vinorelbine (Pacl-Vin) in Hormone-refractory metastatic prostate cancer: Double Tubulin Targeting
Scientific title
A Phase II study of Paclitaxel and Vinorelbine (PaclVin) in Hormone-refractory metastatic prostate cancer: Double Tubulin Targeting. The outcome measured is PSA response.
Universal Trial Number (UTN)
Trial acronym
Pacl-vin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 404 0
Condition category
Condition code
Cancer 475 475 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chemotherapy is given twice every three weeks, ie. Paclitaxel 40mg/m2 IV and Vinorelbine 20mg/m2 IV. The duration of treatment: as long as the treatment is working, or the side effects are tolerable.
Intervention code [1] 280 0
None
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 544 0
PSA response
Timepoint [1] 544 0
Measured at week 6 and week 10.
Secondary outcome [1] 1150 0
Overall survival
Timepoint [1] 1150 0
From day 1 until day of progression or death
Secondary outcome [2] 1151 0
Progression free survival
Timepoint [2] 1151 0
From day 1 until day of progression or death
Secondary outcome [3] 1152 0
Toxicity
Timepoint [3] 1152 0
Every 3 weeks
Secondary outcome [4] 1153 0
Quality of life
Timepoint [4] 1153 0
Every 3 weeks.

Eligibility
Key inclusion criteria
Hormone-refractory prostate cancer with metastases documented by bone scan and/or CT scan, with rising PSA and/or progressive metastatic disease with serum testosterone < 3.5 nmol/L. - Patients who have not had bilateral orchidectomy should continue therapy with a Luteinizing hormone-releasing hormone analogue. Antiandrogens should be ceased at least 28 days prior to study entry. - Adequate bone marrow function: absolute neutrophil count (ANC) at least 1.5 X 109/L and platelets at least 100 X 109/L. - Adequate renal function: serum creatinine less than or equal to 200µmol/L. - Adequate liver function: bilirubin less than or equal to 20µmol/L and AST/ALT less than or equal to 5 X upper limit of normal. - ECOG performance status 0-2. - Not more than one previous line of chemotherapy (prior exposure to vinorelbine and/or taxanes not allowable).
Minimum age
Not stated
Maximum age
Not stated
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prior radiotherapy within 21 days - Prior radioactive strontium within 42 days. - Concurrent treatment with other investigational agents.

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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 535 0
Hospital
Name [1] 535 0
Barwon Health
Address [1] 535 0
Ryrie Street Geelong
Country [1] 535 0
Australia
Funding source category [2] 536 0
Commercial sector/Industry
Name [2] 536 0
Bristol Myers Squibb
Address [2] 536 0
556 Princes Highway

NOBLE PARK NORTH, VICTORIA 3174
Country [2] 536 0
United States of America
Funding source category [3] 537 0
Commercial sector/Industry
Name [3] 537 0
Pierre Fabre Medicament
Address [3] 537 0
International House, Pendlebury Road,
Manchester
Country [3] 537 0
France
Funding source category [4] 538 0
Charities/Societies/Foundations
Name [4] 538 0
Geelong Regional Medical research foundation
Address [4] 538 0
Ryrie street
Geelong
Country [4] 538 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bristol Myers Squibb
Address
556 Princes Highway

NOBLE PARK NORTH, VICTORIA 3174
Country
United States of America
Secondary sponsor category [1] 435 0
Commercial sector/Industry
Name [1] 435 0
Pierre Fabre Medicament
Address [1] 435 0
International House, Pendlebury Road,
Manchester
Country [1] 435 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1534 0
Barwon Health
Ethics committee address [1] 1534 0
Ethics committee country [1] 1534 0
Australia
Date submitted for ethics approval [1] 1534 0
Approval date [1] 1534 0
Ethics approval number [1] 1534 0
Ethics committee name [2] 1535 0
Frankston Hospital
Ethics committee address [2] 1535 0
Ethics committee country [2] 1535 0
Australia
Date submitted for ethics approval [2] 1535 0
Approval date [2] 1535 0
Ethics approval number [2] 1535 0

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

Contacts
Principal investigator
Name 36011 0
Address 36011 0
Country 36011 0
Phone 36011 0
Fax 36011 0
Email 36011 0
Contact person for public queries
Name 9469 0
Anne Woollett
Address 9469 0
Andrew Love Cancer Centre
70 Swanston St
Geelong VIC 3220
Country 9469 0
Australia
Phone 9469 0
+61 3 52267391
Fax 9469 0
+61 3 52465168
Email 9469 0
annewo@barwonhealth.org.au
Contact person for scientific queries
Name 397 0
Dr Sanjeev Sewak
Address 397 0
Andrew Love Cancer Centre
70 Swanston St
Geelong VIC 3220
Country 397 0
Australia
Phone 397 0
+61 3 52267477
Fax 397 0
+61 3 52465168
Email 397 0
sanjeev@barwonhealth.org.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary