Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer
Tracking Information | |
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First Received Date ICMJE | March 30, 2004 |
Last Updated Date | June 30, 2011 |
Start Date ICMJE | July 2003 |
Primary Completion Date | July 2005 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT00080418 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer |
Official Title ICMJE | Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer |
Brief 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. |
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:
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 Type ICMJE | Interventional |
Study Phase | Phase 1 |
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE | Neoplasm |
Intervention ICMJE | Drug: Liposome Entrapped Paclitaxel Easy to Use |
Study Arm (s) | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 40 |
Completion Date | June 2010 |
Primary Completion Date | July 2005 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00080418 |
Other Study ID Numbers ICMJE | LEP-ETU-101-R03 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Insys Therapeutics Inc |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Insys Therapeutics Inc |
Verification Date | June 2011 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |