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Trial registered on ANZCTR


Registration number
ACTRN12611000013965
Ethics application status
Approved
Date submitted
22/12/2010
Date registered
6/01/2011
Date last updated
6/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inter-ethnic differences in tolerance of anti-cancer drugs in non-small cell lung cancer patients
Scientific title
Exploration of differences in tolerance between Caucasian and Asian non-small cell lung cancer patients receiving palliative chemotherapy with carboplatin and paclitaxel
Secondary ID [1] 253329 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tolerance of palliative chemotherapy with carboplatin and paclitaxel in advanced non-small cell lung cancer patients 258869 0
Condition category
Condition code
Cancer 259006 259006 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observe side effects, nutritional status, inflammatory factors and measure drug clearance of the cycle 1 treatment (21 days):
Paclitaxel 175 mg/m2 in 3 hour intravenous infusion, day 0
Carboplatin AUC 6 in 1 hour intravenous infusion, day 0
Collect Deoxyribonucleic acid (DNA) samples for pharmacogenomics purpose
Toxicity observation is implemented during the first cycle only, response observation is implemented after 3 cycles.
Patients recruited over 5 years.
Intervention code [1] 257782 0
Not applicable
Comparator / control treatment
Both Caucasian and Asian patients will receive the exact same treatment during this observational study. Compare side effects and drug clearance between Caucasian and Asian patients
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259863 0
adverse events of the treatment including hematological toxicity, and other toxicity such as nausea, vomiting, diarrhoea, fatigue and mucositis according to common terminology criteria for adverse event v3.0(CTCAE)
Timepoint [1] 259863 0
day 7, day 10 , day 14 and day 21 of cycle 1
Secondary outcome [1] 268735 0
rate of drug clearance measured by using population pharmacokinetics approach with limited sampling model
Timepoint [1] 268735 0
day 0 and day 1 of cycle 1
Secondary outcome [2] 268736 0
single nucleotide polymorphism of gene coding drug metabolizing enzymes measured by rapid throughput genotyping being preformed using high-resolution melt-curve analysis
Timepoint [2] 268736 0
before start of chemotherapy
Secondary outcome [3] 268737 0
nutritional status measured by patient-generated subjective global assessment (PGSGA)
Timepoint [3] 268737 0
before start of chemotherapy

Eligibility
Key inclusion criteria
- Asian or Caucasian patients.
- Histologically confirmed advanced non-small cell lung cancer patients
- receiving chemotherapy with carboplatin AUC 6 and paclitaxel 175 mg/m2
- Age greater than or equal to 18.
- Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2.
- Ability to comply with the planned procedures and provide written evidence of informed consent.
- Adequate haematology and biochemistry. (Haemoglobin>100 g/L, White blood cell count >4.0 x 109/L, neutrophil count > 1.5 × 109, platelets >100 x 109/L; Aspartate transaminase (AST), Alanine transaminase (ALT) and bilirubin < 1.5 x ULN (AST, ALT < 5 x upper limit of normal in case liver metastases); calculated creatinine clearance according to Corkroft formula > 60 ml/min.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who require dose adjustment.
- Clinical evidence of active brain metastases.
- Suspected or documented bone marrow involvement.
- Significant intercurrent illness including active infection, inflammatory bowel disease or other uncontrolled autoimmune disease.
- The requirement for ongoing systemic treatment with corticosteroids or other immunosuppressive therapy.
- Patients who have had chemotherapy 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Ongoing major side effects from radiology.
- Other active malignancy.
- Known allergy to any of the investigational agents.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
Recruitment postcode(s) [1] 3516 0
2139
Recruitment outside Australia
Country [1] 3105 0
China
State/province [1] 3105 0
Shanghai

Funding & Sponsors
Funding source category [1] 258251 0
Government body
Name [1] 258251 0
National Health and Medical Research Council, Australia
Address [1] 258251 0
National Health and Medical Research Council Level 1 16 Marcus Clarke Street Canberra ACT 2601
Country [1] 258251 0
Australia
Primary sponsor type
Hospital
Name
Sydney Cancer Centre
Address
Sydney Cancer Centre, Concord Hospital, Hospital road Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 257418 0
University
Name [1] 257418 0
The University of Sydney
Address [1] 257418 0
Faculty of Medicine, The University of Sydney, NSW 2006
Country [1] 257418 0
Australia
Other collaborator category [1] 251750 0
Hospital
Name [1] 251750 0
Renji Hospital, Shanghai
Address [1] 251750 0
Oncology Department, Renji Hospital, 1630 Dongfang road, Pudong 200122 Shanghai
Country [1] 251750 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260227 0
Human Research Ethics Committee-Concord Repatriation General Hospital Zone
Ethics committee address [1] 260227 0
Sydney South West Area Health Service Human Research Ethics Committee-CRGH Zone Concord Repatriation General Hospital Hospital road Concord NSW 2139
Ethics committee country [1] 260227 0
Australia
Date submitted for ethics approval [1] 260227 0
Approval date [1] 260227 0
26/10/2006
Ethics approval number [1] 260227 0
CH62/6/2006-092
Ethics committee name [2] 260228 0
Human Research Ethics Committee
Ethics committee address [2] 260228 0
Sydney South West Area Health Service Human Research Ethics Committee-RPAH zone Royal Prince Alfred Hospital, Missenden road Camperdown NSW 2050
Ethics committee country [2] 260228 0
Australia
Date submitted for ethics approval [2] 260228 0
Approval date [2] 260228 0
01/12/2006
Ethics approval number [2] 260228 0
X06-0298

Summary
Brief summary
Recent evidence shows an ethnic variability in tolerance of anticancer drugs between Asian and Caucasian non-small cell lung cancer patients. Pharmacogenetic differences in drug metabolising enzymes have been proposed as the cause of these differences, however they have not been associated with altered cytotoxic drug pharmacokinetics (PK). Other possible explanations include differences in dietary/concomitant medicine intake and inflammatory status. The aim of this study was to investigate inter-ethnic differences in cytotoxic drug metabolism, inflammatory/nutritional status, genotype and outcomes between Asian and Caucasian non-small cell lung cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32040 0
Address 32040 0
Country 32040 0
Phone 32040 0
Fax 32040 0
Email 32040 0
Contact person for public queries
Name 15287 0
Prof. Stephen Clarke
Address 15287 0
Sydney Cancer Centre,
Concord Hospital, Hospital road
Concord, NSW 2139
Country 15287 0
Australia
Phone 15287 0
+ 61 2 97676775
Fax 15287 0
Email 15287 0
stephen.clarke@sydney.edu.au
Contact person for scientific queries
Name 6215 0
Prof. Stephen Clarke
Address 6215 0
Sydney Cancer Centre,
Concord Hospital, Hospital road
Concord, NSW 2139
Country 6215 0
Australia
Phone 6215 0
+ 61 2 97676775
Fax 6215 0
Email 6215 0
stephen.clarke@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results