Completed

Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer

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What is being tested

Liposome Entrapped Paclitaxel Easy to Use

Drug
Who is being recruted

Neoplasm

Over 18 Years
+32 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2003

See protocol details

Summary

Principal SponsorINSYS Therapeutics Inc
Last updated: July 4, 2011
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitlePhase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer 
Principal SponsorINSYS Therapeutics Inc
Last updated: July 4, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasm
Criteria
17 inclusion criteria required to participate
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

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15 exclusion criteria prevent from participating
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

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
H. Lee Moffitt Cancer Center and Research InstituteTampa, United StatesSee the location
Suspended
Cancer Institute of New Jersey - University of Medicine and Dentistry of New JerseyNew Brunswick, United States
Suspended
Fox Chase Temple Cancer Center - Temple UniversityPhiladelphia, United States
Completed3 Study Centers