Lung CancerPhase 2NCT00103389
Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing PI-88 and docetaxel in people with Lung Cancer, run by Cellxpert Biotechnology Corp. at 13 sites in Australia.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- PI-88 and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 13 sitesAustralia
- Study dates
- Feb 2004to May 2007
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell lung cancer
- Stage IIIB or IV disease
- Eligible for second-line docetaxel
- Disease progression during or after completion of prior first-line therapy comprising radiotherapy and/or platinum-based chemotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 2 months
Hematopoietic
- Neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- WBC > 3,000/mm^3
- No history of thrombotic thrombocytopenic purpura or other platelet disease
Hepatic
- Bilirubin normal
- ALT and AST ≤ 2.5 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase > 2.5 times ULN)
- Alkaline phosphatase ≤ 5 times ULN (unless bone metastases are present)
- PT < 1.5 times ULN
- Activated PTT normal
Renal
- Creatinine clearance or glomerular filtration rate > 50mL/min
Cardiovascular
- None of the following within the past 3 months:
- Myocardial infarction
- Stroke
- Congestive heart failure
Immunologic
- No history of immune-mediated thrombocytopenia
- No evidence of anti-heparin antibodies
- No history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
- No history of allergy to polysorbate 80
- No uncontrolled or serious infection within the past 4 weeks
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior docetaxel
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 3 months since prior radiotherapy to > 30% of marrow-bearing bone
- Concurrent local palliative radiotherapy allowed
Surgery
- More than 4 weeks since prior major surgery
Other
- More than 4 weeks since prior antineoplastic therapy
- More than 2 weeks since prior and no concurrent heparin or low-molecular weight heparin
- More than 4 weeks since prior investigational therapy
- No concurrent aspirin or aspirin-containing medications except low-dose aspirin (≤ 100 mg/day)
- No concurrent nonsteroidal anti-inflammatory drugs except cyclooxygenase-2 inhibitors
- No concurrent warfarin or warfarin-containing medications except low-dose warfarin (≤ 1 mg/day)
- No concurrent antiplatelet drugs, including any of the following:
- Abciximab
- Clopidogrel
- Dipyridamole
- Ticlopidine
- Tirofiban
- No concurrent drugs that may inhibit docetaxel metabolism, including any of the following:
- Cyclosporine
- Terfenadine
- Ketoconazole
- Erythromycin
- Troleandomycin
- No other concurrent investigational drugs
- No other concurrent antineoplastic therapy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Prince Charles Hospital
Chermside, Queensland, 4032
Sydney Heamatology and Oncology Clinics
Hornsby, New South Wales, 2077
Alfred Hospital
Melbourne, Victoria, 3004
Nambour General Hospital
Nambour, Queensland, 4560
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, 6009
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, 2031
Mater Medical Centre
South Brisbane, Queensland, 4101
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2298
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria, 3690
Queen Elizabeth Hospital
Woodville, South Australia, 5011
About this study
Official title: A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the efficacy markers of docetaxel and PI-88 in these patients.
- Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy.
- Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive docetaxel as in arm I. Patients also receive PI-88 subcutaneously once daily on days 1-4, 8-11, and 15-18.
In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive PI-88 alone as maintenance therapy. Patients in arm I with progressive disease or unacceptable toxicity before the completion of 6 courses may receive PI-88 alone as third-line therapy.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- PI-88, docetaxel
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI-88Drug
PI-88+docetaxel
docetaxelDrug
docetaxel only
| Study group | Role | What they receive |
|---|---|---|
| docetaxel | Active comparator | treated with docetaxel alone Receives: Drug: docetaxel |
| PI-88+docetaxel | Experimental | treated with docetaxel and PI-88 Receives: Drug: PI-88; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Non-progression rate as measured by RECIST v2.0 at 6 months
Secondary outcomes (4)
Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
Overall survival as measured by RECIST v2.0 at death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2005 (estimated)
- Study startFeb 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 98 participants (actual)
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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103389
- Sponsor's protocol ID
- PROGEN-PR88202
- Other IDs
- CDR0000409568, AUS-RNSH-0309-183M
- Status last verified
- Jun 2022
- First submitted
- 7 Feb 2005
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00103389
- Acronym / sponsor ID
- PROGEN-PR88202
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Cellxpert Biotechnology Corp.Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Study start
- Feb 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 8 Feb 2005 (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.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the efficacy markers of docetaxel and PI-88 in these patients.
- Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy.
- Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive docetaxel as in arm I. Patients also receive PI-88 subcutaneously once daily on days 1-4, 8-11, and 15-18.
In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive PI-88 alone as maintenance therapy. Patients in arm I with progressive disease or unacceptable toxicity before the completion of 6 courses may receive PI-88 alone as third-line therapy.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| docetaxel | Active comparator | Drug: docetaxeltreated with docetaxel alone |
| PI-88+docetaxel | Experimental | Drug: PI-88, Drug: docetaxeltreated with docetaxel and PI-88 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PI-88PI-88+docetaxel | Drug | PI-88+docetaxel |
| docetaxeldocetaxel only | Drug | PI-88+docetaxel, docetaxel |
Primary outcome
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Non-progression rate as measured by RECIST v2.0 at 6 months
4 secondary outcomes
Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
Overall survival as measured by RECIST v2.0 at death
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.
- Individual participant dataSharing planned: No
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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
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 PI-88 and docetaxel in people with Lung Cancer, 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?
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?
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months. The study lists 2 primary outcomes in all. 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.