Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046527
Status:
COMPLETED
Last Update Posted:
2006-07-13
First Post:
2002-09-30
Brief Title:
Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer
Sponsor:
Celgene Corporation
Organization:
Celgene Corporation
Study Overview
Official Title:
A Controlled Randomized Phase III Multicenter Open Label Study of ABI-007a Cremophor Free Protein Stabilized Nanoparticle Paclitaxel and Taxol in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Paclitaxel Taxol Bristol-Meyers Squibb has been shown to be very effective against metastatic breast cancer as well as other cancers Because the Taxol formulation of paclitaxel is dissolved in Cremophor an organic solvent containing castor oil and ethanol prolonged intravenous administration times are required and because the solvent has caused hypersensitivity reactions a premedication schedule is required ABI-007 is a new anticancer medication containing the same active ingredient as Taxol paclitaxel but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously The time of administration is reduced the dose of paclitaxel can be higher than is safe for Taxol and there is no premedication required
This study will determine the efficacy of this new formulation of paclitaxel as compared to Taxol for patients with metastatic breast cancer
This is an open label comparative study so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel but will know what medication they are receiving Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication
This study will determine the efficacy of this new formulation of paclitaxel as compared to Taxol for patients with metastatic breast cancer
This is an open label comparative study so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel but will know what medication they are receiving Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication
Detailed Description:
Taxol Bristol-Meyers Squibb is active against carcinomas of the ovary breast lung esophagus and head and neck A number of dose schedules of Taxol have been tested in breast cancer Initial trials used 250 mgm2 as a continuous infusion over 24 hours Subsequently shorter infusions of Taxol over three hours were tested at a dose of 175 mgm2 with response rates of 30-40 Phase II studies using higher doses of Taxol at 200-250 mgm2 had a response rate of 56 in metastatic breast cancer patients However at these doses significant toxicities occurred including neuropathy There was a median granulocyte count nadir at 100-200 cellsmm3 for the majority of courses administered There were also significant side effects associated with hypersensitivity to the Taxol vehicle Cremophor-EL These hypersensitivity reactions require a premedication schedule that includes a corticosteroid an H2 antagonist and an antihistamine
Abraxis BioScience is testing a reformulated form of paclitaxel without Cremophor This formulation is a protein-stabilized nanoparticle suspension of paclitaxel and human serum albumin in normal saline The potential advantages of this formulation are
Higher tolerated doses with greater efficacy
Longer drug persistence in tumor as a result of the nanoparticle formulation
Reduced infusion time
Reduced risk of hypersensitivity with no required premedication schedule
More rapid distribution of paclitaxel to the tissues based on pharmacokinetic data
This study will evaluate ABI-007 as compared to Taxol in patients with metastatic breast cancer
Abraxis BioScience is testing a reformulated form of paclitaxel without Cremophor This formulation is a protein-stabilized nanoparticle suspension of paclitaxel and human serum albumin in normal saline The potential advantages of this formulation are
Higher tolerated doses with greater efficacy
Longer drug persistence in tumor as a result of the nanoparticle formulation
Reduced infusion time
Reduced risk of hypersensitivity with no required premedication schedule
More rapid distribution of paclitaxel to the tissues based on pharmacokinetic data
This study will evaluate ABI-007 as compared to Taxol in patients with metastatic breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None