Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307255
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2006-03-24
Brief Title:
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-04
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 and gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation Abraxane in combination with gemcitabine hydrochloride in patients with advanced metastatic solid tumors
Secondary
Evaluate the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation Abraxane
Patients receive paclitaxel albumin-stabilized nanoparticle formulation Abraxane IV over 30 minutes on day 1 followed by gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation Abraxane until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 10 additional patients may be treated at the MTD
After completion of study treatment patients are followed at 30 days
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation Abraxane in combination with gemcitabine hydrochloride in patients with advanced metastatic solid tumors
Secondary
Evaluate the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation Abraxane
Patients receive paclitaxel albumin-stabilized nanoparticle formulation Abraxane IV over 30 minutes on day 1 followed by gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation Abraxane until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 10 additional patients may be treated at the MTD
After completion of study treatment patients are followed at 30 days
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 |
|---|---|---|---|
| CDR0000550136 | OTHER | PDQ number | None |