Status:
COMPLETED
Pilot Efficacy Study of PI-88 With Docetaxel to Treat Prostate Cancer
Lead Sponsor:
Progen Pharmaceuticals
Collaborating Sponsors:
Northern Sydney and Central Coast Area Health Service
Aventis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Histologically/cytologically proven prostate adenocarcinoma that is unresponsive or refractory to hormone therapy
- Patients must have received prior hormonal therapy, defined as castration by orchiectomy and/or luteinizing hormone releasing hormone (LHRH) agonists
- Patients must have documented progression detected by PSA increase, physical examination and/or imaging
- Patients must have achieved stable pain control for a minimum of seven consecutive days prior to study entry.
- Prior radiation therapy (to \< 25% of the bone marrow only) is permitted. At least 4 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects prior to study entry.
- Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery
- Life expectancy \> 3 months
- ECOG Performance score of \< 2.
- Neutrophil count \> 1.5 x 109/L (1,500/mm3)
- Haemoglobin \> 10 g/dL
- Platelet count \> 100 x 109/L (100,000/mm3)
- Total bilirubin \< the upper limit of normal (ULN) of the institution
- ALT (SGPT) and AST (SGOT) \< 1.5 x the ULN of the institution
- Calculated creatinine clearance, using Cockroft and Gault formula, \>60 mL/min
- APTT and PT \< 1.5 X ULN
- Patients (or legally acceptable representative) must have voluntarily given written informed consent to participate in this study.
- Patients must be willing to comply with the scheduled visit, treatment plans, laboratory tests, and other study procedures
Exclusion
- Prior cytotoxic chemotherapy
- Prior isotope therapy (e.g., strontium, samarium)
- Prior radiotherapy to \>25% of bone marrow (whole pelvic irradiation is not allowed)
- Prior treatment with biological response modifiers within the previous 4 weeks
- Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for \> 5 years
- Known brain or leptomeningeal involvement
- Symptomatic peripheral neuropathy \> grade 2 according to the NCI Common Terminology Criteria for Adverse Events v3 (NCI CTCAE v3)
- Serious intercurrent medical illness that does not permit adequate follow-up and compliance with the study protocol
- History of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies
- Use of drugs that may inhibit the metabolism of docetaxel (cyclosporin, terfenadine, ketoconazole, erythromycin, troleandomycin) within the previous week or during the study
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or over-the-counter (OTC) products for the treatment of prostate cancer must be stopped prior to day of enrolment
- Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped prior to day of enrolment
- Concomitant bisphosphonate therapy is not allowed. Patients already receiving bisphosphonates must be stopped prior to day of enrolment
- Concomitant use of aspirin (\> 150 mg/day), non-steroidal anti-inflammatory drugs (except specific COX-2 inhibitors), heparin, low molecular weight heparin (LMWH), warfarin (\> 1 mg/day) or anti-platelet drugs (abciximab, clopidogrel, dipyridamole, ticlopidine and tirofiban). Low-dose aspirin (≤ 150 mg/day) and low-dose warfarin (≤ 1 mg/day) are permitted as concomitant medications
- Treatment with heparin or low molecular weight heparin within the previous two weeks is not permitted
- History of allergy and/or hypersensitivity to heparin or other anti-coagulants/thrombolytic agents
- History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease or other abnormal bleeding tendency
- Patients at risk of bleeding due to open wounds or planned surgery
- Myocardial infarction, stroke or congestive heart failure within the past three months
- Uncontrolled or serious infection within the past four weeks
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00268593
Start Date
August 1 2005
End Date
February 1 2008
Last Update
June 15 2011
Active Locations (8)
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1
Sydney Haematology and Oncology Clinics
Hornsby, New South Wales, Australia, 2077
2
St George Hospital
Kogarah, New South Wales, Australia, 2217
3
Lismore Base Hospital
Lismore, New South Wales, Australia, 2477
4
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, 2444