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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00097851
Ethics application status
Date submitted
30/11/2004
Date registered
1/12/2004
Date last updated
31/03/2016

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
Gender
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
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,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
Medigen Biotechnology Corporation
Address
Country

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/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

Summary results
Other publications