Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095914
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2004-11-09
Brief Title:
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Randomized Crossover Pharmacokinetic Study Of Paclitaxel Taxol And ABI-007 A Cremophor EL-Free Protein Stabilized Nanoparticle Paclitaxel In Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-03
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:
RATIONALE Drugs used in chemotherapy such as paclitaxel and ABI-007 work in different ways to stop tumor cells from dividing so they stop growing or die Combining paclitaxel with ABI-007 may kill more tumor cells
PURPOSE Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors
PURPOSE Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel
Secondary
Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients
Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients
Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen
OUTLINE This is a randomized pilot study
Courses 1 and 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22
Arm II Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22
Courses 3 and beyond All patients receive ABI-007 IV over 30 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel
Secondary
Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients
Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients
Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen
OUTLINE This is a randomized pilot study
Courses 1 and 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22
Arm II Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22
Courses 3 and beyond All patients receive ABI-007 IV over 30 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000393782 | None | None | None |
| 04-C-0280 | None | None | None |
| ABI-CA019 | None | None | None |