Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499291
Status:
WITHDRAWN
Last Update Posted:
2023-05-25
First Post:
2007-07-10
Brief Title:
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Pharmacokinetic Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel Nanoparticle Albumin Bound-Paclitaxel in Patients With Advanced Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2023-05
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:
RATIONALE Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced or refractory solid tumors
PURPOSE This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced or refractory solid tumors
Detailed Description:
OBJECTIVES
Primary
To develop a population pharmacokinetic model for paclitaxel administered as paclitaxel albumin-stabilized nanoparticle formulation nab-paclitaxel to a large population of patients with advanced or refractory cancer to characterize the inter-individual pharmacokinetic variability of this agent
Secondary
To explore nab-paclitaxel pharmacokinetic parameters in patients with metastatic prostate cancer castrate metastatic breast cancer advanced non-small cell lung cancer and other incurable advanced or refractory tumors amenable to treatment with nab-paclitaxel
To explore the association between exposure to total and unbound paclitaxel after administration of nab-paclitaxel and neutropenia
To explore the association between the CYP2C83 variant and paclitaxel clearance
To explore the association between other variants of CYP2C8 and other genes involved in paclitaxel disposition including CYP3A4 CYP3A5 SLCO1B3 OATP8 and ABCB1 MDR1 and paclitaxel pharmacokinetic parameters and toxicity after one course of treatment
OUTLINE This is a multicenter study
Patients receive paclitaxel albumin-stabilized nanoparticle formulation nab-paclitaxel IV over 30 minutes on days 1 8 15 22 29 36 43 and 50 Treatment may repeat off study every 9 weeks in the absence of disease progression or unacceptable toxicity
Serial blood samplings are obtained at specified time points during course 1 including baseline and days 1 and 8 of course 1 for pharmacokinetic studies Samples are also examined for genotype by PCR including variant genotypes in 2C8 CYP3A4 CYP3A5 ABCB1 ABCC2 ABCC10 and OATP1B3 genes
Primary
To develop a population pharmacokinetic model for paclitaxel administered as paclitaxel albumin-stabilized nanoparticle formulation nab-paclitaxel to a large population of patients with advanced or refractory cancer to characterize the inter-individual pharmacokinetic variability of this agent
Secondary
To explore nab-paclitaxel pharmacokinetic parameters in patients with metastatic prostate cancer castrate metastatic breast cancer advanced non-small cell lung cancer and other incurable advanced or refractory tumors amenable to treatment with nab-paclitaxel
To explore the association between exposure to total and unbound paclitaxel after administration of nab-paclitaxel and neutropenia
To explore the association between the CYP2C83 variant and paclitaxel clearance
To explore the association between other variants of CYP2C8 and other genes involved in paclitaxel disposition including CYP3A4 CYP3A5 SLCO1B3 OATP8 and ABCB1 MDR1 and paclitaxel pharmacokinetic parameters and toxicity after one course of treatment
OUTLINE This is a multicenter study
Patients receive paclitaxel albumin-stabilized nanoparticle formulation nab-paclitaxel IV over 30 minutes on days 1 8 15 22 29 36 43 and 50 Treatment may repeat off study every 9 weeks in the absence of disease progression or unacceptable toxicity
Serial blood samplings are obtained at specified time points during course 1 including baseline and days 1 and 8 of course 1 for pharmacokinetic studies Samples are also examined for genotype by PCR including variant genotypes in 2C8 CYP3A4 CYP3A5 ABCB1 ABCC2 ABCC10 and OATP1B3 genes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E1Y06 | None | None | None |