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Trial registered on ANZCTR


Registration number
ACTRN12615000504516
Ethics application status
Approved
Date submitted
23/02/2015
Date registered
20/05/2015
Date last updated
22/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of nab-Paclitaxel in combination with capecitabine as second line treatment of advanced biliary cancer.
Scientific title
Patients with advanced biliary cancer to be treated with second line combination chemotherapy of NAB Paclitaxel and capecitabine in a single arm pilot study to assess feasibility
Secondary ID [1] 285570 0
Nil
Universal Trial Number (UTN)
U1111-1162-5085
Trial acronym
NAP-CAPABIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advanced biliary cancer 293402 0
Condition category
Condition code
Cancer 293683 293683 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single arm, second line combination chemotherapy using nab-Paclitaxel and capecitabine. Nab-Paclitaxel (125mg/m2) will be administered intravenously (IV) on days 1 and 8 of each 21 day cycle. Capecitabine (825mg/m2) will be administered orally (PO) twice daily on days 1-14 of each 21 day cycle. Chemotherapy will continue until disease progression. Drug accountability checks will be performed prior to each cycle to monitor compliance.
Intervention code [1] 290524 0
Treatment: Drugs
Comparator / control treatment
There is currently no standard second line treatment for patients with advanced biliary cancer
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293498 0
Feasibility of delivering second line treatment in advanced biliary cancer
Timepoint [1] 293498 0
Recruitment rate as measured by time taken to recruit 10 patients. The study aims to recruit 10 patients within 2 years.
Primary outcome [2] 294489 0
Safety and tolerability of treatment
Timepoint [2] 294489 0
As determined by incidence and severity of adverse events (toxicity). Toxicity assessments are done prior to each cycle of chemotherapy.
Secondary outcome [1] 311176 0
Objective clinical benefit is defined as stable disease or better in response to the treatment. The tumour will be measured using by CT imaging by RECIST criteria.
Timepoint [1] 311176 0
Tumour assessment by CT imaging is done 6 weeks post registration and every 12 weeks whilst on treatment.
Secondary outcome [2] 313440 0
Progression free survival is defined from date of registration on the study to the date of first evidence of disease progression.
Timepoint [2] 313440 0
Disease progression will be assessed by CT imaging at 6 weeks post registration and then every 12 weeks on treatment.
Secondary outcome [3] 313441 0
Overall survival
Timepoint [3] 313441 0
Overall survival is defined as interval from date of registration on the study to the date of death from any cause or last known date of follow up.
Secondary outcome [4] 313442 0
Patient reported Quality of Life
Timepoint [4] 313442 0
Quality of Life will be assessed using the EORTC QOL questionnaire prior to each cycle of chemotherapy and then at end of treatment and every 12 weeks thereafter.

Eligibility
Key inclusion criteria
1. Histologically proven unresectable biliary tract cancer
2. Prior chemotherapy with gemcitabine/platinum. Patient must have either progressed on chemotherapy or be intolerant to either drug.
3. >18 years
4. Measurable disease according to RECIST
5. Good performance status
6. Adequate bone marrow function
7. Adequate hepatic function
8. Adequate renal function
9 Planned to start treatment within 30 days of registration
10. Willing and able to comply with study requirements
11. Signed, written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous treatment with a taxane or fluoropyrimidines
2. Prior hypersensitivity to paclitaxel or albumin
3. Significant underlying medical conditions that may be aggravated by study treatment
4. Significant peripheral neuropathy
5. Life expectancy of less than 3 months
6. Untreated brain metastases or leptomeningeal disease
7. History of another malignancy within 2 years prior to registration.
8. Concurrent illness including severe infection
9. Presence of any psychological, familial, sociological or geographical condition that may hamper compliance
10. Pregnancy, lactation, or inadequate contraception

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)
Participants will be identified at their treating centre, approached about participating in the study and if willing, will sign informed consent. Screening procedures will then be undertaken to determine eligibility for this single-arm study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive analyses

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)
NSW
Recruitment hospital [1] 3105 0
Illawarra Cancer Care Centre (The Wollongong Hospital)
Recruitment hospital [2] 3106 0
St George Hospital - Kogarah
Recruitment hospital [3] 3108 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 3109 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 3501 0
Campbelltown Hospital - Campbelltown

Funding & Sponsors
Funding source category [1] 290174 0
Commercial sector/Industry
Name [1] 290174 0
Specialised Therapeutics Australia Pty Ltd
Address [1] 290174 0
711 High Street
East Kew, Victoria 3102
Country [1] 290174 0
Australia
Primary sponsor type
Government body
Name
Illawarra and Shoalhaven Local Health District
Address
Research Governance Office
Level 8, The Wollongong Hospital
Loftus Street
Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 288884 0
None
Name [1] 288884 0
Address [1] 288884 0
Country [1] 288884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291882 0
University of Wollongong/Illawarra Shoalhaven Local Health District Health and Medical HREC
Ethics committee address [1] 291882 0
Level 1, Building 20
Research Services Office
University of Wollongong
Wollongong NSW 2522
Ethics committee country [1] 291882 0
Australia
Date submitted for ethics approval [1] 291882 0
16/10/2014
Approval date [1] 291882 0
27/01/2015
Ethics approval number [1] 291882 0
AU/1/5D1B17

Summary
Brief summary
This pilot study will determine the feasibility of a second line combination chemotherapy of NAB-Paclitaxel and capecitabine for the treatment of advance biliary cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have histologically proven unresectable biliary tract cancer and have had prior chemotherapy treatment with gemcitabine/platinum.

Study Details:
All participants will receive combination chemotherapy using NAB-Paclitaxel and Capecitabine for as long as their disease responds to treatment and will be followed up every 12 weeks (until death) after end of treatment with CT imaging, status and quality of life assessments in order to determine feasibility, clinical benefit, survival rates and impact of treatment on quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52414 0
A/Prof Morteza Aghmesheh
Address 52414 0
Illawarra Cancer Care Centre
The Wollongong Hospital
Lock Bag 8808
South Coast Mail Centre
Wollongong NSW 2521
Country 52414 0
Australia
Phone 52414 0
+61242225200
Fax 52414 0
Email 52414 0
morteza.aghmesheh@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 52415 0
A/Prof Morteza Aghmesheh
Address 52415 0
Illawarra Cancer Care Centre
The Wollongong Hospital
Lock Bag 8808
South Coast Mail Centre
Wollongong NSW 2521
Country 52415 0
Australia
Phone 52415 0
+61 242225200
Fax 52415 0
Email 52415 0
ISLHDCancerClinicalTrials@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 52416 0
A/Prof Morteza Aghmesheh
Address 52416 0
Illawarra Cancer Care Centre
The Wollongong Hospital
Lock Bag 8808
South Coast Mail Centre
Wollongong NSW 2521
Country 52416 0
Australia
Phone 52416 0
+61 242225200
Fax 52416 0
Email 52416 0
ISLHDCancerClinicalTrials@sesiahs.health.nsw.gov.au

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