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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: 081964
ACTR Number: ACTRN12607000221459
Trial Status: Registered
Date Submitted: 16/04/2007
Date Registered: 23/04/2007

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Public title: Effect of chemotherapy and growth factor on cancer and stem cells in blood.
ANZCTR registration 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.
Secondary ID: 
UTN:
Trial acronym:

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

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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:Treatment: drugs 
Comparator / control treatment: Receiving standard chemotherapy (docetaxel 100mg/m2 every 3 weeks)
Control group: Uncontrolled

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Primary outcome 1:1. 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:Analysed on the same day as blood is collected. 
Primary outcome 2:2. 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:Analysed on the same day as blood is collected. 
Secondary outcome 1:1. To study relation between CD34+ progenitor cells and CTCs at different time points on the blood sample collected on D4-D11 and D21. 
Timepoint:The secondary outcomes will be analysed on the same day as blood is collected. 
Secondary outcome 2:2. To estimate difference between baseline and peak CD34+ progenitor cells and CTCs on the blood sample collected on D4-D11 and D21. 
Timepoint:The secondary outcomes will be analysed on the same day as blood is collected. 
Secondary outcome 3:3. 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:The secondary outcomes will be analysed on the same day as blood is collected. 

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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
Gender: Both males and females
Healthy volunteers? 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.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Single group
Other design features (specify):
Type of endpoint(s): Pharmacokinetics

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Phase Phase 2
Anticipated or actual date of first participant enrolement: 1/05/2007
Target sample size: 10
Recruitment status: Open to recruitment

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Funding source:Commercial sector/Industry 
Name:Amgen Australia Pty Ltd 
Address: 
Country:Australia 
Primary sponsor: Hospital
Name: Department of Medical Oncology, Royal Adelaide Hospital
Address:
Country: Australia
Secondary sponsor:None 
Name:None 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Royal Adelaide Hospital 
Address: 
Country:Australia 
Date of approval:27/03/2007 
HREC Number:070216 
Countries of recruitment:Australia 
Brief summary: Use of chemotherapy and growth factors can affect the number of stem cells and cancer cells in blood circulation. Few studies have also shown that number of cancer cells can be of prognostic significance. There are no studies till date which have looked systematically at the influence of chemotherapy and growth factors on these cells. Hence present study was designed to answer these questions. The results of the study may not directly influence the way we treat the patients today but will definitely help us to understand the complex nature of breast cancer.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Nimit Singhal
Address: Department of Medical Oncology Level 7 East Wing Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country: Australia
Tel: +61 8 82224398
Fax: +61 8 82224358
Email: nsinghal@mail.rah.sa.gov.au

Contact person for scientific queries
Name: Nimit Singhal
Address: Department of Medical Oncology Level 7 East Wing Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country: Australia
Tel: +61 8 82224398
Fax: +61 8 82224358
Email: nsinghal@mail.rah.sa.gov.au

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