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Pilot Efficacy Study of PI-88 With Docetaxel to Treat Prostate Cancer

NCT00268593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-06-15

No results posted yet for this study

Summary

Docetaxel (Taxotere) is an approved chemotherapeutic drug for the treatment of androgen-independent prostate cancer. The aim of the study is to investigate whether addition of the investigational drug PI-88 will increase the efficacy of docetaxel in this disease. PI-88 inhibits cancer growth by inhibiting the development of new blood vessels and starving the tumour of oxygen and nutrients (anti-angiogenic). Because PI-88 and docetaxel have different mechanisms of action, they are expected to have increased (synergistic) activity when combined.

Conditions

Interventions

DRUG

PI-88

Subcutaneous injection administered 7 days/week for 130 mg PI-88 and 4 days/week for 250 mg PI-88; patients to be treated until progression or withdrawal from study.

DRUG

docetaxel

Subcutaneous injection administered 7 days/week for 130 mg PI-88 and 4 days/week for 250 mg PI-88; patients to be treated until progression or withdrawal from study.

DRUG

prednisone

5 mg twice a day orally

Sponsors & Collaborators

  • Northern Sydney and Central Coast Area Health Service

    collaborator OTHER

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Progen Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gavin Marx, MD · Sydney Haematology and Oncology Clinics

  • Nick Pavlakis, MD · Royal North Shore Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00268593 on ClinicalTrials.gov