Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000307404
Ethics application status
Approved
Date submitted
6/07/2005
Date registered
6/07/2005
Date last updated
6/07/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase II trial of docetaxel (Taxotere) in combination with PI88 for men with androgen independent prostate cancer
Scientific title
A randomised phase II study of PSA (prostate specific antigen) response and safety of two dose schedules of PI-88 in combination with docetaxel in patients with androgen-independent prostate cancer
Universal Trial Number (UTN)
Trial acronym
ProPIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lead in tolerance study (proceed to next dose level if no dose limiting toxicity) cohort 1: 190mg PI-88 4 days/week (sub cutaneously) + docetaxel 75 mg/msquared on day1 (D1)(Intravenous) (total weekly dose of PI-88 = 760 mg)
cohort 2: 250 mg of PI-88 4 days/week + docetaxel 75 mg/msquared D1 (total weekly dose of PI-88 = 1000 mg)
cohort 3: 190 mg PI-88 7 days/week + docetaxel 75 mg/msquared D1 (total weekly dose of PI-88 = 1330 mg)
cohort 4: 250 mg PI-88 7 days/week + docetaxel 75 mg/msquared D1(total weekly dose of PI-88 = 1750 mg). Once dose established will proceed to the randomised phase 2 component comparing a Day1-7 (D1-7)PI88 protocol vs a day 1-4 PI 88 protocol. Patients will be randomly allocated to receive docetaxel intravenously (75mg/m2) on day 1 and PI-88 subcutaneous injections (250mg) 4 days/week over a 3 week cycle or Docetaxel intravenously (75mg/m2) on day 1 and PI-88 subcutaneous injections (130mg) 7 days/week over a 3 week cycle. Treatment will continue for as long as benefit is shown (stable or objective response) or until patients have evidence of disease progression or are withdrawn from study treatment for other reasons. This study will continue until a minimum of 35 patients are recruited to each treatment arm, and all patients have completed study treatment. The results from this study will determine the efficacy and feasibility of the combination of docetaxel, prenisone and 2 regimens of PI-88 in the treatment of Androgen Independent prostate cancer.
Intervention code [1] 1157 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes

Eligibility
Key inclusion criteria
Minimum age
Maximum age
Sex
Can healthy volunteers participate?
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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
82
Accrual to date
Final

Funding & Sponsors
Primary sponsor type
Name
Address
Country

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This is a randomised phase II trial of 2 dose levels of PI88 incombination with docetaxel to assess the safety and efficacy of this combination of cytotoxic chemotherapy with an antiangiogenic agent
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35741 0
Address 35741 0
Country 35741 0
Phone 35741 0
Fax 35741 0
Email 35741 0
Contact person for public queries
Name 10346 0
Gavin Marx
Address 10346 0
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Australia
Country 10346 0
Phone 10346 0
+61 2 94765844
Fax 10346 0
+61 2 94821341
Email 10346 0
gmarx@shoc.com.au
Contact person for scientific queries
Name 1274 0
Gavin Marx
Address 1274 0
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Australia
Country 1274 0
Phone 1274 0
+61 2 94765844
Fax 1274 0
+61 2 94821341
Email 1274 0
gmarx@shoc.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.