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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00097851




Registration number
NCT00097851
Ethics application status
Date submitted
30/11/2004
Date registered
1/12/2004
Date last updated
27/06/2022

Titles & IDs
Public title
Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
Scientific title
Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
Secondary ID [1] 0 0
PR88202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - docetaxel
Treatment: Drugs - PI-88

Treatment: Drugs: docetaxel


Treatment: Drugs: PI-88
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time to progression
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Response rate
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quality of life
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed
during or after first-line treatment

- measurable disease by spiral CT chest scan, as defined in RECIST criteria

- performance status 0-1 (ECOG)

- life expectancy at least 2 months

- adequate hemopoietic, renal and hepatic function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- current symptomatic central nervous system (CNS) involvement

- prior or co-existent malignancies

- significant non-malignant disease

- acute or chronic gastrointestinal (GI) bleeding in last two years

- inflammatory bowel disease

- abnormal bleeding tendency

- patients at risk of bleeding due to open wounds or planned surgery

- clinically significant hemoptysis within the past 4 weeks

- bilirubin > upper limit of normal (ULN)

- ALT and AST > 2.5 times ULN, or > 1.5 times ULN if alkaline phosphatase > 2.5 times
ULN

- alkaline phosphatase > 5 times ULN, unless patient has bone metastases

- myocardial infarction, stroke or congestive heart failure within last 3 months

- prior treatment with docetaxel

- concomitant treatment with aspirin (>100 mg/day), NSAIDs (except selective COX-2
inhibitors, warfarin (>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4
inhibitors

- women who are pregnant or breast-feeding

- women of child-bearing potential not using adequate contraception

- history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents,
especially heparin

- history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or
other platelet disease

- allergy to polysorbate 80 (component of Taxotere®)

- uncontrolled or serious infection in last 4 weeks

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Cancer Centre, Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Sydney Haematology and Oncology Clinics - Hornsby
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [6] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [7] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [8] 0 0
Mater Hospital - South Brisbane
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [11] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [12] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2077 - Hornsby
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
4560 - Nambour
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5011 - Woodville
Recruitment postcode(s) [11] 0 0
3187 - Prahran
Recruitment postcode(s) [12] 0 0
3690 - Wodonga
Recruitment postcode(s) [13] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cellxpert Biotechnology Corp.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medigen Biotechnology Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new
blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients
with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based
drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months
after starting docetaxel treatment. The PR88202 study has been designed to compare two
different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which
is more effective against the cancer. It is hoped that the combination of PI-88 with
docetaxel will allow patients to extend the time it takes for their disease to progress, and
also to improve their quality of life.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00097851
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nick Pavlakis, MD
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries