The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000520932
Ethics application status
Not yet submitted
Date submitted
11/08/2010
Date registered
20/05/2011
Date last updated
20/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I/IIa trial of HA-Irinotecan, a formulation of hyaluronic acid and irinotecan, in the treatment of extensive stage small cell lung cancer and its effect on tumour stem cells.
Scientific title
A Phase I/IIa trial of HA-Irinotecan, a formulation of hyaluronic acid and irinotecan, in the treatment of extensive stage small cell lung cancer and its effect on tumour stem cells.
Secondary ID [1] 252416 0
Alchemia Oncology ACO-003
Universal Trial Number (UTN)
Trial acronym
HA-Irinotecan small cell lung cancer trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
small cell lung cancer 257927 0
Condition category
Condition code
Cancer 258097 258097 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HA-Irinotecan, a formulation of hyaluronic acid and Irinotecan at 150 mg/m2 and carboplatin AUC 5 administered as an intravenous infusion on day one of a 21 day cycle. Maximum of 6 cycles
Intervention code [1] 256982 0
Treatment: Drugs
Comparator / control treatment
Irinotecan at 150 mg/m2 and carboplatin AUC 5 administered as an intravenous infusion on day one of a 21 day cycle. Maximum of 6 cycles
Control group
Active

Outcomes
Primary outcome [1] 258957 0
Incidence of Grade 3 and 4 toxicity as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.02 (2009)
Timepoint [1] 258957 0
End of treatment (6 months folowing randomisation)
Primary outcome [2] 258958 0
Tumour stem cell burden during and at conclusion of study as measured by CD44, CD133 stained cells from lung core biopsy
Timepoint [2] 258958 0
End of study (12 months following randomisation)
Secondary outcome [1] 265127 0
Cumulative dose of Irinotecan as measured by infusions received
Timepoint [1] 265127 0
End of treatment (6 months following randomisation)
Secondary outcome [2] 265128 0
Progression free survival rate at 6 months as measured radiologically
Timepoint [2] 265128 0
6 months post randomisation
Secondary outcome [3] 265129 0
Objective response rates as determined by computed tomography (CT) scans using RECIST 1.1
Timepoint [3] 265129 0
End of study (12 months following randomisation)
Secondary outcome [4] 265130 0
Quality of life as measured by 3 validated tools: McGill Quality of Life Quesionnaire (MQOL), Social Support Scale, and Hospital anxiety and depression scale (HADS)
Timepoint [4] 265130 0
End of study (12 months following randomisation)
Secondary outcome [5] 265131 0
Survival outcome by clinic visit/phone call
Timepoint [5] 265131 0
End of study (12 months following randomisation)

Eligibility
Key inclusion criteria
Patients must fulfill all of the following criteria to be eligible for admission to the study:
18 years of age and older
Male or female
Histologically or cytologically confirmed small cell lung cancer, that is defined as a previously untreated metastatic or extensive disease:
Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease.
Prior radiotherapy allowed.
Measurable disease, defined as 1 unidimensionally measurable lesion equal to1 cm by physical examination or radiographic techniques
Known brain metastases allowed.
Eastern Cooperative Oncology Group(ECOG) performance status 0-2
Life expectancy greater than 3 months
Haematology done within 7 days prior to first treatment and with initial values within the ranges specified below (transfusions are appropriate to bring patients into the appropriate ranges, however, there must be no evidence of active bleeding):
White Blood cell count greater than 3,000/mm^3
Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin greater than 9.0 g/dL
Biochemistry done within 7 days prior to first treatment and with initial values within the ranges specified below:
Bilirubin greater than1.5 mg/dL
Alanine transaminase greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Not pregnant or nursing
Negative pregnancy test
Women of child-bearing potential (WOCBP) and male partners of WOCBP must agree to use adequate contraception prior to study entry, throughout the study and for a period of 3 months after cessation of protocol therapy. WOCBP include any women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhoea > 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level greater than 35 mIU/mL). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or who are practicing abstinence or whose partner is sterile (eg., vasectomized) should be considered to be of child-bearing potential.
No medical disease that, in the opinion of the investigator, would preclude study treatment
Imaging investigations including at least chest computed tomography (CT) or Magnetic Resonane Imaging (MRI) scan and CT or MRI of abdomen/pelvis with other scans as necessary to document all sites of disease, done within 28 days prior to treatment. Contrast enhancement should be used if no contraindication. The same imaging method should be used for the patient throughout the entire study (e.g. if a patient starts with CT scans all subsequent imaging should be with CT scans).
At least 10 days since prior radiotherapy (including brain)
At least 2 weeks since prior and no concurrent anticonvulsants
No concurrent radiotherapy.
The patient must sign the consent form prior to registration.
The baseline assessment must be completed within 7 days prior to first treatment.
Patients must be accessible for treatment and follow-up. Investigators must assure themselves that patients registered on this trial will be available for complete documentation of the treatment, toxicity, and follow-up. Patients enrolled in this trial must be treated at the participating centre.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who fulfill any of the following criteria are not eligible for admission to the study:
Previous exposure to any chemotherapy for small cell lung cancer
Bilirubin greater than 1.5 mg/dL
ECOG greater than 2
Active inflammatory bowel disease or any chronic diarrhoea grade 2.
Bulky disease (>50% hepatic involvement, >25% lung involvement, or abdominal mass 10 cm) due to an increased risk of toxicity.
Radiotherapy within the preceding 4 weeks, unless to a single bone site.
Documented unsuitability for irinotecan includes known hypersensitivity to a camptothecin drug, abnormal glucuronidation of bilirubin or Gilbert’s syndrome.
Patients receiving treatment with phenobarbitone, St John’s Wort, phenytoin or valproate.
Partial or complete bowel obstruction.
Concomitant active infection.
Currently active second malignancy, other than non-melanoma skin cancers.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with interpretation of study results.
Pregnant or lactating women or women of childbearing potential not using adequate contraception.
Any active pathological condition that would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
Any condition (e.g., psychological, geographical) that does not permit compliance with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be allocated treatment number by independant organisation. Treatment number will be unmasked by clincial trials pharmacist. Every one else will be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random 1:1 allocation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
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)
VIC

Funding & Sponsors
Funding source category [1] 257443 0
Commercial sector/Industry
Name [1] 257443 0
Alchemia Oncology
Address [1] 257443 0
Educational grant
Department of Biochemistry and Molecular Biology, Monash University, Wellington Rd, Clayton 3800, Victoria
Country [1] 257443 0
Australia
Primary sponsor type
Hospital
Name
Southern Health
Address
246 Clayton Rd
Clayton 3168
Victoria
Country
Australia
Secondary sponsor category [1] 256671 0
Hospital
Name [1] 256671 0
Southern Health
Address [1] 256671 0
Monash Medical Centre
865 Centre Rd
East Bentleigh
Victoria 3165
Country [1] 256671 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259464 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 259464 0
246 Clayton Rd
Clayton 3168
Victoria
Ethics committee country [1] 259464 0
Australia
Date submitted for ethics approval [1] 259464 0
04/02/2010
Approval date [1] 259464 0
Ethics approval number [1] 259464 0
10007A

Summary
Brief summary
This study looks at whether the addition of HA-Irinotecan to standard carboplatin chemotherapy improves disease response and quality of life as well as targeting possible lung cancer stem cells in advanced small cell lung cancer. Who is it for? You can join this study if you are 18 years or older, have Histologically or cytologically confirmed small cell lung cancer, and fill all of the rest of the inclusion criteria for this study (please see the inclusion criteria field earlier in this form). Trial details Participants will be randomised to one of two treatment arms, (1) HA-Irinotecan, a formulation of hyaluronic acid and Irinotecan at 150 mg/m2 combined with carboplatin AUC 5 administered as an intravenous infusion on day one of a 21 day cycle for a maximum of 6 cycles, or (2) Irinotecan at 150 mg/m2 and carboplatin AUC 5 administered as an intrvenous infusion on day one of a 21 day cycle. Maximum of 6 cycles. The trial will aim to investigate the usefulness of these drug combinations on the treatment of extensive stage small cell lung cancer, the level of their toxicity, and its effect on tumour stem cells.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31501 0
Address 31501 0
Country 31501 0
Phone 31501 0
Fax 31501 0
Email 31501 0
Contact person for public queries
Name 14748 0
Peter Midolo
Address 14748 0
Monash Medical Centre
865 Centre Rd
East Bentleigh 3165
Victoria
Country 14748 0
Australia
Phone 14748 0
+61 3 9928 8195
Fax 14748 0
+61 3 9928 8543
Email 14748 0
peter.midolo@southernhealth.org.au
Contact person for scientific queries
Name 5676 0
Dr Vinod Ganju
Address 5676 0
Monash Medical Centre
865 Centre Rd
East Bentleigh
Victoria 3165
Country 5676 0
Australia
Phone 5676 0
+61 3 9928 8120
Fax 5676 0
+61 3 9928 8341
Email 5676 0
vg@poc.com.au

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