Status:
COMPLETED
Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
Lead Sponsor:
Cellxpert Biotechnology Corp.
Collaborating Sponsors:
Medigen Biotechnology Corporation
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-sma...
Detailed Description
PR88202 is an open-label randomized study. In the initial phase of the study, patients will be randomized to receive weekly docetaxel alone, or PI-88 in combination with weekly docetaxel. Both groups ...
Eligibility Criteria
Inclusion
- histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment
- measurable disease by spiral CT chest scan, as defined in RECIST criteria
- performance status 0-1 (ECOG)
- life expectancy at least 2 months
- adequate hemopoietic, renal and hepatic function
Exclusion
- current symptomatic central nervous system (CNS) involvement
- prior or co-existent malignancies
- significant non-malignant disease
- acute or chronic gastrointestinal (GI) bleeding in last two years
- inflammatory bowel disease
- abnormal bleeding tendency
- patients at risk of bleeding due to open wounds or planned surgery
- clinically significant hemoptysis within the past 4 weeks
- bilirubin \> upper limit of normal (ULN)
- ALT and AST \> 2.5 times ULN, or \> 1.5 times ULN if alkaline phosphatase \> 2.5 times ULN
- alkaline phosphatase \> 5 times ULN, unless patient has bone metastases
- myocardial infarction, stroke or congestive heart failure within last 3 months
- prior treatment with docetaxel
- concomitant treatment with aspirin (\>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (\>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors
- women who are pregnant or breast-feeding
- women of child-bearing potential not using adequate contraception
- history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
- history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease
- allergy to polysorbate 80 (component of Taxotere®)
- uncontrolled or serious infection in last 4 weeks
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00097851
Start Date
February 1 2004
End Date
July 1 2006
Last Update
June 27 2022
Active Locations (13)
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1
Sydney Cancer Centre, Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Sydney Haematology and Oncology Clinics
Hornsby, New South Wales, Australia, 2077
3
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
4
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065