- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00097851
Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
June 21, 2022 updated by: Cellxpert Biotechnology Corp.
Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
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-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy).
Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment.
The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer.
It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 will receive docetaxel (30 mg/m2), administered by intravenous infusion on days 1, 8 and 15 of a 28-day cycle.
The second group only will receive PI-88 (250 mg/day) in addition to docetaxel; PI-88 will be administered by subcutaneous injection on days 1-4, 8-11 and 15-18 of each cycle.
The primary efficacy endpoint is the non-progression rate at 6 months.
In the extension phase of the study, patients in the combination arm who have stable disease or an objective response after up to six treatment cycles will remain on PI-88 alone as maintenance therapy.
Patients who initially receive docetaxel alone and who have disease progression or unacceptable toxicity before the completion of six cycles will be eligible to receive PI-88 alone as third-line therapy.
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Sydney Cancer Centre, Royal Prince Alfred Hospital
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Hornsby, New South Wales, Australia, 2077
- Sydney Haematology and Oncology Clinics
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Randwick, New South Wales, Australia, 2031
- Prince of Wales Hospital
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St Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Waratah, New South Wales, Australia, 2298
- Newcastle Mater Misericordiae Hospital
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Queensland
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Chermside, Queensland, Australia, 4032
- Prince Charles Hospital
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Nambour, Queensland, Australia, 4560
- Nambour General Hospital
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South Brisbane, Queensland, Australia, 4101
- Mater Hospital
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Woodville, South Australia, Australia, 5011
- The Queen Elizabeth Hospital
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Victoria
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Prahran, Victoria, Australia, 3187
- The Alfred Hospital
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Wodonga, Victoria, Australia, 3690
- Border Medical Oncology
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Time to progression
|
Response rate
|
Overall survival
|
Quality of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Nick Pavlakis, MD, Royal North Shore Hospital
- Study Director: Paul Mitchell, MD, Austin and Repatriation Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
November 30, 2004
First Submitted That Met QC Criteria
November 30, 2004
First Posted (Estimate)
December 1, 2004
Study Record Updates
Last Update Posted (Actual)
June 27, 2022
Last Update Submitted That Met QC Criteria
June 21, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- PR88202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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