Lung CancerPhase 2NCT00748163
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
- paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Aug 2008
- 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
Who may be able to join
- ECOG performance status 0-1
- WBC ≥ 3.0 x 10^9/L
- ANC ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver has tumor involvement)
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- Creatinine ≤ 1.5 mg/dL
- LVEF ≥ 40% by MUGA
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Who cannot join
- Congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 12 months
- Ongoing severe or unstable angina
- Unstable arrhythmia requiring medication
- Sensory neuropathy ≥ grade 2 (according to NCI CTCAE v3.0)
- Known hypersensitivity to any of the agents used in this study
- Serious medical or psychiatric illness that, in the opinion of the enrolling investigator, is likely to interfere with study participation
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- PRIOR CONCURRENT THERAPY:
- No prior systemic therapy for NSCLC
- More than 4 weeks since prior major surgery
- More than 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following:
- Ketoconazole
- Itraconazole
- Clarithromycin
- Erythromycin
- Diltiazem
- Verapamil
- Delavirdine
- Indinavir
- Saquinavir
- Ritonavir
- Atazanavir
- Nelfinavir
- More than 12 days since prior and no concurrent potent CYP3A4 inducers, including any of the following:
- Rifampin
- Rifabutin
- Carbamazepine
- Phenobarbital
- Phenytoin
- St. John's wort
- Efavirenz
- Tipranavir
- No concurrent treatment with a drug having proarrhythmic potential, including any of the following:
- Terfenadine
- Quinidine
- Procainamide
- Disopyramide
- Sotalol
- Probucol
- Bepridil
- Haloperidol
- Risperidone
- Indapamide
- Flecainide
- No other concurrent investigational agents
About this study
Official title: Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib works as first-line therapy in treating patients with stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the tumor response rate in patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
Secondary
- To determine the time to objective tumor response and duration of response in responding patients.
- To determine the time to treatment failure and overall survival of these patients.
- To characterize the toxicities of this regimen in these patients.
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months for up to 1 year.
- Conditions
- Lung Cancer
- Being tested
- paclitaxel albumin-stabilized nanoparticle formulation, sunitinib malate
- Keywords
- 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.
paclitaxel albumin-stabilized nanoparticle formulationDrug
sunitinib malateDrug
| Study group | Role | What they receive |
|---|---|---|
| Stage IV Non-Small Cell Lung Cancer Patients | Experimental | Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy. Receives: Drug: paclitaxel albumin-stabilized nanoparticle formulation; Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 1 Year
Secondary outcomes (5)
Time to objective tumor response as assessed by RECIST criteria
Measured: 1 Year
Duration of response
Measured: 1 Year
Time to treatment failure
Measured: 1 Year
Overall survival
Measured: 1 Year
Toxicity and adverse events as assessed by NCI CTCAE v3.0
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startAug 2008 (estimated)
- Primary completionAug 2008 (estimated)
- Study completionAug 2008 (estimated)
Why it stopped: Study has been abandoned for lack of available funding.
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.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkadiusz Dudek, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748163
- Sponsor's protocol ID
- 2007LS098
- Other IDs
- 0802M26201, ABX080, GA6181W
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2008
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00748163
- Acronym / sponsor ID
- 2007LS098
- Conditions
- Lung Cancer
- Keywords
- stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been abandoned for lack of available funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2008 (estimated)
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 8 Sep 2008 (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 paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib works as first-line therapy in treating patients with stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the tumor response rate in patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
Secondary
- To determine the time to objective tumor response and duration of response in responding patients.
- To determine the time to treatment failure and overall survival of these patients.
- To characterize the toxicities of this regimen in these patients.
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage IV Non-Small Cell Lung Cancer Patients | Experimental | Drug: paclitaxel albumin-stabilized nanoparticle formulation, Drug: sunitinib malatePatients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ECOG performance status 0-1
- WBC ≥ 3.0 x 10^9/L
- ANC ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Bilirubin ≤ 1.5 mg/dL
Key exclusion criteria (44 listed)
- Congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 12 months
- Ongoing severe or unstable angina
- Unstable arrhythmia requiring medication
- Sensory neuropathy ≥ grade 2 (according to NCI CTCAE v3.0)
- Known hypersensitivity to any of the agents used in this study
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 |
|---|---|---|
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Stage IV Non-Small Cell Lung Cancer Patients |
| sunitinib malate | Drug | Stage IV Non-Small Cell Lung Cancer Patients |
Primary outcome
Response rate
Time frame: 1 Year
5 secondary outcomes
Time to objective tumor response as assessed by RECIST criteria
Time frame: 1 Year
Duration of response
Time frame: 1 Year
Time to treatment failure
Time frame: 1 Year
Overall survival
Time frame: 1 Year
Toxicity and adverse events as assessed by NCI CTCAE v3.0
Time frame: 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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.
Arkadiusz Dudek, MD principal investigator
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota.
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 11 inclusion and 44 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: withdrawn, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Response rate (time frame: 1 Year). 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 8 Aug 2018.