Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284752
Status:
COMPLETED
Last Update Posted:
2012-10-01
First Post:
2006-01-30
Brief Title:
Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer based on prostate specific antigen PSA response
Detailed Description:
Taxanes are the most widely tested and effective chemotherapy drugs for hormone refractory prostate cancer Weekly paclitaxel was reported to produce 25-39 PSA responses in first line and up to 33 in second line chemotherapy of patients with prostate cancer in early clinical trials 1 2 Paclitaxel activity in prostate cancer is schedule dependent and weekly paclitaxel was reported to produce highest response rates 1 2 Docetaxel was recently approved by the Food and Drug Administration for treatment of hormone refractory metastatic prostate cancer since it is the only chemotherapy drug with documented improvement in survival in this group of patients Docetaxel was associated with 458 overall grade 34 toxicities and it has to be given with steroid pre-medication This regimen might be difficult to use in advanced prostate cancer patients that are often elderly and with multiple co-morbid conditions
ABI-007 Abraxane paclitaxel protein-bound particles for injectable suspension albumin-bound is the first in its class of biologically interactive albumin-bound forms of chemotherapy 3 This composition provides a novel approach of increasing intra-tumoral concentration of the drug by a receptor-mediated transport process allowing transcytosis across the endothelial cell wall thereby breaching the bloodtumor interface This albumin-specific receptor mediated process involves the binding of a specific receptor gp60 on the endothelial cell wall resulting in activation of a protein caveolin-1 which initiates an opening in the endothelial wall with formation of a little caves or caveolae with transport of the albumin-bound chemotherapeutic complex via these caveolae to the underlying tumor interstitium 4 A protein specifically secreted by the tumor SPARC binds and entraps the albumin allowing release of the hydrophobic drug to the tumor cell membrane ABI-007 is the first biologically interactive albumin-bound chemotherapy agent leveraging this gp-60caveolin-1caveolaeSparc pathway to increase intra-tumoral concentration of the drug and reduce the amount of the toxic chemotherapy in normal tissue
Preclinical studies comparing Abraxane to paclitaxel demonstrated lower toxicities with a maximum tolerated dose MTD approximately 50 higher for Abraxane 7 compared to paclitaxel 11 At equal doses there was less myelosuppression and improved efficacy than paclitaxel in a xenograft tumor model of human mammary adenocarcinoma Clinical studies confirmed improved toxicity profile and higher response rates in metastatic breast cancer of Abraxane compared to cremophor EL paclitaxel Taxol 5 8 The weekly regimen was shown to be active even in patients with cancers refractory to paclitaxel docetaxel or when Abraxane was given after both agents 8
ABI-007 Abraxane paclitaxel protein-bound particles for injectable suspension albumin-bound is the first in its class of biologically interactive albumin-bound forms of chemotherapy 3 This composition provides a novel approach of increasing intra-tumoral concentration of the drug by a receptor-mediated transport process allowing transcytosis across the endothelial cell wall thereby breaching the bloodtumor interface This albumin-specific receptor mediated process involves the binding of a specific receptor gp60 on the endothelial cell wall resulting in activation of a protein caveolin-1 which initiates an opening in the endothelial wall with formation of a little caves or caveolae with transport of the albumin-bound chemotherapeutic complex via these caveolae to the underlying tumor interstitium 4 A protein specifically secreted by the tumor SPARC binds and entraps the albumin allowing release of the hydrophobic drug to the tumor cell membrane ABI-007 is the first biologically interactive albumin-bound chemotherapy agent leveraging this gp-60caveolin-1caveolaeSparc pathway to increase intra-tumoral concentration of the drug and reduce the amount of the toxic chemotherapy in normal tissue
Preclinical studies comparing Abraxane to paclitaxel demonstrated lower toxicities with a maximum tolerated dose MTD approximately 50 higher for Abraxane 7 compared to paclitaxel 11 At equal doses there was less myelosuppression and improved efficacy than paclitaxel in a xenograft tumor model of human mammary adenocarcinoma Clinical studies confirmed improved toxicity profile and higher response rates in metastatic breast cancer of Abraxane compared to cremophor EL paclitaxel Taxol 5 8 The weekly regimen was shown to be active even in patients with cancers refractory to paclitaxel docetaxel or when Abraxane was given after both agents 8
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