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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
000306
ACTR Number:
ACTRN12605000316606
Trial Status:
Registered
Date Submitted:
26/08/2005
Date Registered:
6/09/2005
Page 1
Public title:
A Phase II study of Paclitaxel, and Vinorelbine (Pacl-Vin) in Hormone-refractory metastatic prostate cancer: Double Tubulin Targeting
Update:
Reason:
ANZCTR registration 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.
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Reason:
Secondary ID:
UTN:
Update:
Reason:
Trial acronym:
Pacl-vin
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Page 2
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer
Condition category:
Condition code:
Cancer
Prostate
Page 3
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.
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Reason:
Intervention code:
None
Comparator / control treatment:
uncontrolled
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Reason:
Control group:
Uncontrolled
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Reason:
Page 4
Primary outcome:
PSA response
Timepoint:
Measured at week 6 and week 10.
Secondary outcome 1:
Overall survival
Timepoint:
From day 1 until day of progression or death
Secondary outcome 2:
Progression free survival
Timepoint:
From day 1 until day of progression or death
Secondary outcome 3:
Toxicity
Timepoint:
Every 3 weeks
Secondary outcome 4:
Quality of life
Timepoint:
Every 3 weeks.
Page 5
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).
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Reason:
Minimum Age:
Not stated
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Reason:
Maximum Age:
Not stated
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Gender:
Males
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Reason:
Healthy volunteers?
No
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Reason:
Key exclusion criteria:
Prior radiotherapy within 21 days - Prior radioactive strontium within 42 days. - Concurrent treatment with other investigational agents.
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Reason:
Page 6
Study type:
Interventional
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Reason:
Purpose of the study:
Treatment
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Allocation to intervention:
Nonrandomised trial
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Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
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Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
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Reason:
Masking / blinding:
Open (masking not used)
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Reason:
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Assignment:
Single group
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Reason:
Other design features (specify):
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Reason:
Type of endpoint(s):
Efficacy
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Reason:
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Page 7
Phase
Phase 2
Update:
Reason:
Anticipated or actual date of first participant enrolement:
5/05/2004
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Reason:
Target sample size:
30
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Reason:
Recruitment status:
Closed: follow-up complete
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Reason:
Page 8
Funding source 1:
Hospital
Name:
Barwon Health
Address:
Ryrie Street Geelong
Country:
Australia
Funding source 2:
Commercial sector/Industry
Name:
Bristol Myers Squibb
Address:
556 Princes Highway NOBLE PARK NORTH, VICTORIA 3174
Country:
United States of America
Funding source 3:
Commercial sector/Industry
Name:
Pierre Fabre Medicament
Address:
International House, Pendlebury Road, Manchester
Country:
France
Funding source 4:
Charities/Societies/Foundations
Name:
Geelong Regional Medical research foundation
Address:
Ryrie street Geelong
Country:
Australia
Primary sponsor:
Commercial sector/Industry
Update:
Reason:
Name:
Bristol Myers Squibb
Update:
Reason:
Address:
556 Princes Highway NOBLE PARK NORTH, VICTORIA 3174
Update:
Reason:
Country:
United States of America
Update:
Reason:
Secondary sponsor:
Commercial sector/Industry
Name:
Pierre Fabre Medicament
Address:
International House, Pendlebury Road, Manchester
Country:
France
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name 1:
Barwon Health
Address:
Country:
Australia
Date of approval:
HREC Number:
Ethics Committee name 2:
Frankston Hospital
Address:
Country:
Australia
Date of approval:
HREC Number:
Countries of recruitment:
Australia
Brief summary:
Update:
Reason:
Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Anne Woollett
Update:
Reason:
Address:
Andrew Love Cancer Centre 70 Swanston St Geelong VIC 3220
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Reason:
Country:
Australia
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Reason:
Tel:
+61 3 52267391
Update:
Reason:
Fax:
+61 3 52465168
Update:
Reason:
Email:
annewo@barwonhealth.org.au
Update:
Reason:
Contact person for scientific queries
Name:
Dr Sanjeev Sewak
Update:
Reason:
Address:
Andrew Love Cancer Centre 70 Swanston St Geelong VIC 3220
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 3 52267477
Update:
Reason:
Fax:
+61 3 52465168
Update:
Reason:
Email:
sanjeev@barwonhealth.org.au
Update:
Reason:
Contact person responsible for updating information
Name:
Anne Woollett
Update:
Reason:
Address:
Andrew Love Cancer centre, 70 Swanston Street, Geelong Victoria 3220
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
03 5226 7391
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Reason:
Fax:
03 52 46 5168
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Reason:
Email:
annewo@barwonhealth.org.au
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Reason:
