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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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
Control group

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

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
Both males and females
Can healthy volunteers participate?
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
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 1909 0
State/province [1] 1909 0

Funding & Sponsors
Funding source category [1] 237364 0
Name [1] 237364 0
Hellenic Cooperative Oncology Group
Address [1] 237364 0
18, Hatzikostandi str, 11524, Athens
Country [1] 237364 0
Primary sponsor type
Hellenic Cooperative Oncology Group
18, Hatzikostandi str, 11524, Athens
Secondary sponsor category [1] 236859 0
Name [1] 236859 0
Address [1] 236859 0
Country [1] 236859 0

Ethics approval
Ethics application status

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

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
Phone 13180 0
Fax 13180 0
Email 13180 0
Contact person for scientific queries
Name 4108 0
Evangelos Briasoulis
Address 4108 0
Medical Oncology Dept, Ioannina University Hospital, 45110 Ioannina
Country 4108 0
Phone 4108 0
+30 26510 99635
Fax 4108 0
+30 26510 99394
Email 4108 0

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