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Sponsors and Collaborators: |
Progen Pharmaceuticals Northern Sydney and Central Coast Health Aventis Pharmaceuticals |
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Information provided by: | Progen Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00268593 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: PI-88 Drug: docetaxel Drug: prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Phase II Study of Two Dose Schedules of PI-88 in Combination With Docetaxel in Patients With Androgen-Independent Prostate Cancer |
Estimated Enrollment: | 82 |
Study Start Date: | August 2005 |
Study Completion Date: | February 2008 |
The trial is a multi-centre, open-label randomised phase II study in patients with androgen-independent prostate cancer (AIPC), with a lead-in combination tolerance study. The aim of the lead-in phase is to establish the maximum tolerated dose (MTD) of PI-88 administered either 4 days/week or 7 days/week) in combination with fixed doses of docetaxel (75 mg/m^2 every 21 days) and prednisone (5 mg twice daily). In the randomized phase II component, patients will receive PI-88 at the MTD, either 4 days/week or 7 days/week, in combination with docetaxel and prednisone. The patients will receive up to 10 treatment cycles of the combination therapy. Response to treatment will be assessed by measuring serum levels of prostate specific antigen (PSA). Other efficacy measures will include radiological assessment, progression-free survival, overall survival and quality of life.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
Royal North Shore Hospital | |
St Leonards, New South Wales, Australia, 2065 | |
Sydney Haematology and Oncology Clinics | |
Hornsby, New South Wales, Australia, 2077 | |
Port Macquarie Base Hospital | |
Port Macquarie, New South Wales, Australia, 2444 | |
Lismore Base Hospital | |
Lismore, New South Wales, Australia, 2477 | |
St George Hospital | |
Kogarah, New South Wales, Australia, 2217 | |
Liverpool Cancer Therapy Centre | |
Randwick, New South Wales, Australia, 2031 | |
Australia, South Australia | |
Ashford Cancer Centre | |
Ashford, South Australia, Australia, 5035 | |
Australia, Victoria | |
Border Medical Oncology | |
Wodonga, Victoria, Australia, 3690 |
Study Chair: | Gavin Marx, MD | Sydney Haematology and Oncology Clinics |
Study Chair: | Nick Pavlakis, MD | Royal North Shore Hospital |
Study ID Numbers: | PR88206, PROPIT, XRP6976J/6216 |
Study First Received: | December 20, 2005 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00268593 |
Health Authority: | United States: Food and Drug Administration; Australia: Therapeutic Goods Administration |
heparanase angiogenesis |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Anti-Inflammatory Agents Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |