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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00103389




Registration number
NCT00103389
Ethics application status
Date submitted
7/02/2005
Date registered
8/02/2005

Titles & IDs
Public title
Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Scientific title
A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
Secondary ID [1] 0 0
CDR0000409568
Secondary ID [2] 0 0
PROGEN-PR88202
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Active comparator: docetaxel - treated with docetaxel alone

Experimental: PI-88+docetaxel - treated with docetaxel and PI-88


Treatment: Drugs: PI-88
PI-88+docetaxel

Treatment: Drugs: docetaxel
docetaxel only
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Timepoint [1] 0 0
Primary outcome [2] 0 0
Non-progression rate as measured by RECIST v2.0 at 6 months
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Overall survival as measured by RECIST v2.0 at death
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer

* Stage IIIB or IV disease
* Eligible for second-line docetaxel

* Disease progression during or after completion of prior first-line therapy comprising radiotherapy and/or platinum-based chemotherapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* At least 2 months

Hematopoietic

* Neutrophil count > 1,500/mm^3
* Platelet count > 100,000/mm^3
* WBC > 3,000/mm^3
* No history of thrombotic thrombocytopenic purpura or other platelet disease

Hepatic

* Bilirubin normal
* ALT and AST = 2.5 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase > 2.5 times ULN)
* Alkaline phosphatase = 5 times ULN (unless bone metastases are present)
* PT < 1.5 times ULN
* Activated PTT normal

Renal

* Creatinine clearance or glomerular filtration rate > 50mL/min

Cardiovascular

* None of the following within the past 3 months:

* Myocardial infarction
* Stroke
* Congestive heart failure

Immunologic

* No history of immune-mediated thrombocytopenia
* No evidence of anti-heparin antibodies
* No history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
* No history of allergy to polysorbate 80
* No uncontrolled or serious infection within the past 4 weeks

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics
* No prior docetaxel

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* More than 3 months since prior radiotherapy to > 30% of marrow-bearing bone
* Concurrent local palliative radiotherapy allowed

Surgery

* More than 4 weeks since prior major surgery

Other

* More than 4 weeks since prior antineoplastic therapy
* More than 2 weeks since prior and no concurrent heparin or low-molecular weight heparin
* More than 4 weeks since prior investigational therapy
* No concurrent aspirin or aspirin-containing medications except low-dose aspirin (= 100 mg/day)
* No concurrent nonsteroidal anti-inflammatory drugs except cyclooxygenase-2 inhibitors
* No concurrent warfarin or warfarin-containing medications except low-dose warfarin (= 1 mg/day)
* No concurrent antiplatelet drugs, including any of the following:

* Abciximab
* Clopidogrel
* Dipyridamole
* Ticlopidine
* Tirofiban
* No concurrent drugs that may inhibit docetaxel metabolism, including any of the following:

* Cyclosporine
* Terfenadine
* Ketoconazole
* Erythromycin
* Troleandomycin
* No other concurrent investigational drugs
* No other concurrent antineoplastic therapy
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
1/05/2007
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Heamatology and Oncology Clinics - Hornsby
Recruitment hospital [2] 0 0
Institute of Oncology at Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [5] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [8] 0 0
Nambour General Hospital - Nambour
Recruitment hospital [9] 0 0
Mater Medical Centre - South Brisbane
Recruitment hospital [10] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [11] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Murray Valley Private Hospital and Cancer Treatment Centre - Wodonga
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Perth - Perth
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4032 - Chermside
Recruitment postcode(s) [8] 0 0
4560 - Nambour
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
5011 - Woodville
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
3690 - Wodonga
Recruitment postcode(s) [13] 0 0
6009 - Perth

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00103389