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Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors

2014-08-27 03:53:54 | BioPortfolio

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.

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.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
United States
20892-1182

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:54-0400

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Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.

A group of 16-member MACROLIDES which stabilize MICROTUBULES in a manner similar to PACLITAXEL. They were originally found in the myxobacterium Sorangium cellulosum, now renamed to Polyangium (MYXOCOCCALES).

Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL).

A condition in which albumin level in blood (SERUM ALBUMIN) is below the normal range. Hypoalbuminemia may be due to decreased hepatic albumin synthesis, increased albumin catabolism, altered albumin distribution, or albumin loss through the urine (ALBUMINURIA).

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