Carcinoma, Non-Small-Cell LungPhase 2NCT00097851
Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
A Phase 2 study testing docetaxel and PI-88 in people with Carcinoma, Non-Small-Cell Lung, run by Cellxpert Biotechnology Corp. at 13 sites in Australia.
Trial 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-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- docetaxel and PI-88
- How many people
- 100 participants
- Where
- 13 sitesAustralia
- Study dates
- Feb 2004to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
Sydney Cancer Centre, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Prince Charles Hospital
Chermside, Queensland, 4032
Sydney Haematology and Oncology Clinics
Hornsby, New South Wales, 2077
Nambour General Hospital
Nambour, Queensland, 4560
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
The Alfred Hospital
Prahran, Victoria, 3187
Prince of Wales Hospital
Randwick, New South Wales, 2031
Mater Hospital
South Brisbane, Queensland, 4101
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2298
Border Medical Oncology
Wodonga, Victoria, 3690
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- docetaxel, PI-88
- Keywords
- second-line, combination, chemotherapy, anti-angiogenic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
PI-88Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Secondary outcomes (4)
Time to progression
Response rate
Quality of life
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2004 (estimated)
- Study startFeb 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Cellxpert Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Responsible party
- Sponsor
- Investigators
- Nick Pavlakis, MD, Study chair, Royal North Shore HospitalPaul Mitchell, MD, Study director, Austin and Repatriation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097851
- Sponsor's protocol ID
- PR88202
- Status last verified
- Jun 2022
- First submitted
- 30 Nov 2004
- Last updated
- 27 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00097851
- Acronym / sponsor ID
- PR88202
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- second-line, combination, chemotherapy, anti-angiogenic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Cellxpert Biotechnology Corp.Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Study start
- Feb 2004
- Study completion
- Jul 2006 (actual)
- First posted
- 1 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| PI-88 | Drug | – |
Primary outcome
Progression-free survival
4 secondary outcomes
Time to progression
Response rate
Quality of life
Overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Pavlakis, MD study chair
Royal North Shore Hospital
Paul Mitchell, MD study director
Austin and Repatriation Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and PI-88 in people with Carcinoma, Non-Small-Cell Lung, run by Cellxpert Biotechnology Corp. at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.