Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00499291|
Recruitment Status : Withdrawn
First Posted : July 11, 2007
Last Update Posted : October 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: pharmacological study Procedure: polymerase chain reaction||Not Applicable|
- 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.
- 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 CYP2C8*3 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel (Nanoparticle Albumin Bound-Paclitaxel) in Patients With Advanced Solid Tumors|
|Study Start Date :||September 2006|
|Estimated Primary Completion Date :||October 2007|
- Inter-individual pharmacokinetic variability
- Pharmacokinetic parameters
- CYP2C8*3 variant expression
- Genetic variance relating to pharmacokinetics and toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499291
|Study Chair:||Sridhar Mani, MD||Albert Einstein College of Medicine|