Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000221459
Ethics application status
Approved
Date submitted
16/04/2007
Date registered
23/04/2007
Date last updated
23/04/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of chemotherapy and growth factor on cancer and stem cells in blood.
Scientific title
A research study to evaluate the kinetics of mobilisation of blood stem cells and circulating tumour cells in response to docetaxel chemotherapy and pegfilgrastim.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 1751 0
Condition category
Condition code
Cancer 1843 1843 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is a research study where patients who are receiving standard chemotherapy (docetaxel 100mg/m2 every 3 weeks) and growth factor (pegfilgrastim 6 mg subcutaneous injection 24 hours after chemotherapy) for metastatic breast cancer will be asked to give blood sample (10 ml) daily from Day 4- Day 11 after first dose of chemotherapy. One more blood sample will be collected on D21. There will not be any further assessment or follow-up as part of the trial. The blood sample will be analysed for stem cells and tumor cells and the effect of treatment will be studied. The patients will continue to receive their treatment as part of routine care.
Intervention code [1] 1702 0
Treatment: Drugs
Comparator / control treatment
Receiving standard chemotherapy (docetaxel 100mg/m2 every 3 weeks)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2581 0
1. To study the peak and duration of CD34+ progenitor cells in peripheral blood after a single dose of pegfilgrastim and docetaxel analysed on blood samples collected between D4-D11 and D21.
Timepoint [1] 2581 0
Analysed on the same day as blood is collected.
Primary outcome [2] 2582 0
2. To study the peak and duration of CTCs (circulating tumor cells) in peripheral blood after a single dose of pegfilgrastim and docetaxel analysed on blood samples collected between D4-D11 and D21.
Timepoint [2] 2582 0
Analysed on the same day as blood is collected.
Secondary outcome [1] 4440 0
1. To study relation between CD34+ progenitor cells and CTCs at different time points on the blood sample collected on D4-D11 and D21.
Timepoint [1] 4440 0
The secondary outcomes will be analysed on the same day as blood is collected.
Secondary outcome [2] 4441 0
2. To estimate difference between baseline and peak CD34+ progenitor cells and CTCs on the blood sample collected on D4-D11 and D21.
Timepoint [2] 4441 0
The secondary outcomes will be analysed on the same day as blood is collected.
Secondary outcome [3] 4442 0
3. To study up regulation or down regulation of various cell surface receptors including CXCR4 on the blood sample collected on D4-D11 and D21.
Timepoint [3] 4442 0
The secondary outcomes will be analysed on the same day as blood is collected.

Eligibility
Key inclusion criteria
1. Able to consent 2. Cytological or histological diagnosis of breast cancer 3. Evidence of metastases 4. Being considered for docetaxel chemotherapy 5. performance status = 2. 6. Adequate organ functionHematological- Hb> 90g/L, Absolute Neutrophil Count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L.Liver function - bilirubin = 2 x upper limit normal (ULN), Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT)/ Alkaline Phosphatase (ALP) = 2.5 x ULN or = 5 x ULN in presence of liver metastases, S. albumin = 30 g/L.Renal function- Creatinine = 2 ULN, Creatinine clearance > 30 mL/min.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Splenomegaly as detected clinically2. Previous treatment with docetaxel.3. Prior pelvic irradiation.4. Pregnancy or lactation. 5. Active second malignancy or past history of any cancer with in last 5 years.6. Patients on other investigational drugs within last 30 days.

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
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1990 0
Commercial sector/Industry
Name [1] 1990 0
Amgen Australia Pty Ltd
Country [1] 1990 0
Australia
Primary sponsor type
Hospital
Name
Department of Medical Oncology, Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 1802 0
None
Name [1] 1802 0
None
Address [1] 1802 0
Country [1] 1802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3697 0
Royal Adelaide Hospital
Ethics committee address [1] 3697 0
Ethics committee country [1] 3697 0
Australia
Date submitted for ethics approval [1] 3697 0
Approval date [1] 3697 0
27/03/2007
Ethics approval number [1] 3697 0
070216

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

Contacts
Principal investigator
Name 27805 0
Address 27805 0
Country 27805 0
Phone 27805 0
Fax 27805 0
Email 27805 0
Contact person for public queries
Name 10891 0
Nimit Singhal
Address 10891 0
Department of Medical Oncology
Level 7 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 10891 0
Australia
Phone 10891 0
+61 8 82224398
Fax 10891 0
+61 8 82224358
Email 10891 0
nsinghal@mail.rah.sa.gov.au
Contact person for scientific queries
Name 1819 0
Nimit Singhal
Address 1819 0
Department of Medical Oncology
Level 7 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 1819 0
Australia
Phone 1819 0
+61 8 82224398
Fax 1819 0
+61 8 82224358
Email 1819 0
nsinghal@mail.rah.sa.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.