NeoplasmPhase 1NCT00080418
Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer
A Phase 1 study testing Liposome Entrapped Paclitaxel Easy to Use in people with Neoplasm, run by INSYS Therapeutics Inc at 3 sites in United States.
Trial summary
The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- Liposome Entrapped Paclitaxel Easy to Use
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2003to Jun 2010
- Phase
- Phase 1
- 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
- Patients must have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments, and no life-prolonging therapy or therapy with a greater potential for patient benefit is available.
- Patients must have an ECOG Performance Status of 0-2.
- Patients must have recovered from acute toxicities of prior treatment:
- ≥ 4 weeks must have elapsed since receiving any investigational agent.
- ≥ 3 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥ 6 weeks for mitomycin or nitrosureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
- > 6 months must have elapsed since receiving a high-dose chemotherapy regime with stem cell support.
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- ≥ 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
- Patients must be in adequate condition as evidenced by the following clinical laboratory values:
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0 g/dL
- Albumin ≥ 3.0 g/dl
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤2.5 x ULN.
- Patients (male and female) must be willing to practice an effective method of birth control during the study.
- Patients or legal representative must understand the investigational nature of this study and sign and Institutional Review Board (IRB) approved written informed consent form prior to treatment.
Who cannot join
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Any active infection requiring parenteral or oral antibiotic treatment.
- Known infection with human immunodeficiency virus (HIV) or hepatitis virus.
- Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or arrhythmias currently requiring medication.
- Known or suspected active central nervous system metastasis. (Patients stable 8 weeks after completion of treatment for central nervous system metastasis are eligible.)
- Impending or symptomatic spinal cord compression or carcinomatous meningitis.
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- Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2 neuromotor or Grade 2 neurosensory) except for abnormalities due to cancer.
- Having received prior treatment with LEP-ETU.
- Having known hypersensitivity to paclitaxel or liposomes.
- Receiving any agent that could interfere with LEP-ETU metabolism, including CYP3A4 inducers and inhibitors within 3 weeks prior to, or while receiving, study drug. (Please refer to http://medicine.iupui.edu/flockhart/ for a list of such agents).
- Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
- Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
- Female patients who are pregnant or breast feeding.
- Unwilling or unable to follow protocol requirements.
- Any condition which, in the Investigator's opinion, deems the patient an unsuitable candidate to receive study drug.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08903
Fox Chase Temple Cancer Center - Temple University
Philadelphia, Pennsylvania, 19140
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer
The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer.
Read the detailed description
LEP-ETU is a new formulation of the anti-cancer agent paclitaxel for injection or Taxol (paclitaxel and Cremophor EL). Paclitaxel is a drug currently used for treating a broad range of cancers. Paclitaxel is thought to prevent cells from dividing and growing, resulting in cell death. This new formulation consists of paclitaxel associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). It is believed that LEP-ETU will maintain or enhance the anti-tumor properties of paclitaxel, while offering advantages to the patient of a shorter infusion time, routine premedication not required, fewer side effects at similar doses, and possibly greater effectiveness, especially if higher doses can be delivered without an increase in side effects.
This study is designed to determine the following:
- The highest dose of LEP-ETU that can be given safely to patients.
- The pharmacokinetics of paclitaxel following intravenous infusion with LEP-ETU.
- Any anti-tumor effects of LEP-ETU.
Up to 8 dose levels will be studied. LEP-ETU will be given to patients by intravenous infusion over 90 minutes, once every 21 days, until their disease progresses or side effects occur requiring the treatments to end. Patients will be evaluated for safety and how well they tolerate the treatments.
- Conditions
- Neoplasm
- Being tested
- Liposome Entrapped Paclitaxel Easy to Use
- Keywords
- neoplasm, cancer, NeoPharm, liposomes, Taxol, paclitaxel, anti-cancer, advanced neoplasm, advanced cancer, chemotherapy, refractory cancer, metastatic cancer
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome Entrapped Paclitaxel Easy to UseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2004 (estimated)
- Study startJul 2003
- Primary completionJul 2005
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080418
- Sponsor's protocol ID
- LEP-ETU-101-R03
- Status last verified
- Jun 2011
- First submitted
- 30 Mar 2004
- Last updated
- 4 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00080418
- Acronym / sponsor ID
- LEP-ETU-101-R03
- Conditions
- Neoplasm
- Keywords
- neoplasm, cancer, NeoPharm, liposomes, Taxol, paclitaxel, anti-cancer, advanced neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Apr 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.
The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer.
Detailed description
LEP-ETU is a new formulation of the anti-cancer agent paclitaxel for injection or Taxol (paclitaxel and Cremophor EL). Paclitaxel is a drug currently used for treating a broad range of cancers. Paclitaxel is thought to prevent cells from dividing and growing, resulting in cell death. This new formulation consists of paclitaxel associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). It is believed that LEP-ETU will maintain or enhance the anti-tumor properties of paclitaxel, while offering advantages to the patient of a shorter infusion time, routine premedication not required, fewer side effects at similar doses, and possibly greater effectiveness, especially if higher doses can be delivered without an increase in side effects.
This study is designed to determine the following:
- The highest dose of LEP-ETU that can be given safely to patients.
- The pharmacokinetics of paclitaxel following intravenous infusion with LEP-ETU.
- Any anti-tumor effects of LEP-ETU.
Up to 8 dose levels will be studied. LEP-ETU will be given to patients by intravenous infusion over 90 minutes, once every 21 days, until their disease progresses or side effects occur requiring the treatments to end. Patients will be evaluated for safety and how well they tolerate the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (17 listed)
- Patients must have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments, and no life-prolonging therapy or therapy with a greater potential for patient benefit is available.
- Patients must have an ECOG Performance Status of 0-2.
- Patients must have recovered from acute toxicities of prior treatment:
- Patients must be in adequate condition as evidenced by the following clinical laboratory values:
- Patients (male and female) must be willing to practice an effective method of birth control during the study.
Key exclusion criteria (15 listed)
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Any active infection requiring parenteral or oral antibiotic treatment.
- Known infection with human immunodeficiency virus (HIV) or hepatitis virus.
- Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or arrhythmias currently requiring medication.
- Known or suspected active central nervous system metastasis. (Patients stable 8 weeks after completion of treatment for central nervous system metastasis are eligible.)
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 |
|---|---|---|
| Liposome Entrapped Paclitaxel Easy to Use | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposome Entrapped Paclitaxel Easy to Use in people with Neoplasm, run by INSYS Therapeutics Inc at 3 sites in United States.
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 17 inclusion and 15 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 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 4 Jul 2011.