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Trial registered on ANZCTR


Registration number
ACTRN12609000790246
Ethics application status
Approved
Date submitted
28/07/2009
Date registered
10/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I trial of carboplatin in combination with irinotecan and paclitaxel split-dosed on days 1 and 8
Scientific title
Phase I study of the maximum dose tolerability of carboplatin-irinotecan-paclitaxel combination (CIP) in patients with advanced refractory solid tumours
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with advanced refractory cancers 237303 0
Condition category
Condition code
Cancer 239626 239626 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a dose escalation study of irinotecan and paclitaxel given on days 1 and 8 in combination with carboplatin standard-dosed every three weeks. To investigate the maximum tolerated dose of irinotecan and pacitaxel split-dosed on days 1 and 8 in combination of carboplatin given in single effusion on day 1 before irinotecan and paclitaxel. n patients with solid tumors. Treatment will be recycled every three weeks and will continue to a maximum eight cycles in patients deriving clinical benefit in the absence of dose limiting toxicity
Intervention code [1] 236981 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238413 0
The Maximum Tolerated Dose (MTD) for this study is defined to be the dose at which 30% of a cohort of six patient patients would suffer unacceptable dose limiting toxicity due to the therapy.Toxicity will be assessed through clinical evaluation and laboratory tests performed every week with patients seen at outpatient clinics
Timepoint [1] 238413 0
4 weeks from start of treatment
Secondary outcome [1] 244892 0
Dose limiting toxicity (DLT) for this study is defined: a) any grade 3 and higher non haematological toxicity except nausea/vomiting, b) any grade 4 haematological toxicity of >4 days duration without G-CSFc) a combination of concurrent diarrhoea grade 2 with granulocytopenia grade 3. d) a re-treatment delay due to toxicity > 2 weeks
Timepoint [1] 244892 0
within the first 4 weeks

Eligibility
Key inclusion criteria
Performance status: World Health Organization (WHO) 2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 3,000/mm3 Absolute lymphocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminase no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiovascular: myocardial infarction within 6 months. Current, uncontrolled cardiac arrhythmias. History of anaphylactic reactions. Pregnancy. Serious uncontrolled, concurrent medical disorders.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
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 outside Australia
Country [1] 1909 0
Greece
State/province [1] 1909 0

Funding & Sponsors
Funding source category [1] 237364 0
Other
Name [1] 237364 0
Hellenic Cooperative Oncology Group
Address [1] 237364 0
18, Hatzikostandi str, 11524, Athens
Country [1] 237364 0
Greece
Primary sponsor type
Other
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostandi str, 11524, Athens
Country
Greece
Secondary sponsor category [1] 236859 0
None
Name [1] 236859 0
Address [1] 236859 0
Country [1] 236859 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The primary objective of this trial is to determine the maximum-tolerated and recommended dosed of split-dosed irinotecan and paclitaxel when combined with carboplatin in patients with metastatic or recurrent refractory malignancies. Secondary objective was to evaluate the toxicity and safety of this combination regimen in this patient population and obtain preliminary data of activity. Cohorts of 3 to 6 patients will receive escalating doses of irinotecan and paclitaxel until the maximum tolerated dose is determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29933 0
Address 29933 0
Country 29933 0
Phone 29933 0
Fax 29933 0
Email 29933 0
Contact person for public queries
Name 13180 0
Eleni Papakostaki
Address 13180 0
Hellenic Cooperative Oncology Group, 18, Hatzikostandi str, 11524, Athens
Country 13180 0
Greece
Phone 13180 0
+302106912520
Fax 13180 0
+302106912713
Email 13180 0
hecogoff@otenet.gr
Contact person for scientific queries
Name 4108 0
Evangelos Briasoulis
Address 4108 0
Medical Oncology Dept, Ioannina University Hospital, 45110 Ioannina
Country 4108 0
Greece
Phone 4108 0
+30 26510 99635
Fax 4108 0
+30 26510 99394
Email 4108 0
ebriasou@otenet.gr

No information has been provided regarding IPD availability
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