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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00499291
Recruitment Status : Withdrawn
First Posted : July 11, 2007
Last Update Posted : October 8, 2015
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

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.

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

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Inter-individual pharmacokinetic variability

Secondary Outcome Measures :
  1. Pharmacokinetic parameters
  2. Neutropenia
  3. CYP2C8*3 variant expression
  4. Genetic variance relating to pharmacokinetics and toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Patients must have an incurable advanced or refractory tumor amenable to treatment with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)

    • Per the National Comprehensive Cancer Network, the following cancer sites have been shown to be responsive to taxane therapy:

      • Prostate cancer
      • Breast cancer
      • Non-small cell lung cancer
      • Bladder cancer
      • Head and neck cancer
      • Oral cancer
      • Cervical cancer
      • Ovarian cancer
      • Endometrial cancer
      • Esophageal cancer
      • Gastric cancer
      • Germ cell tumors
      • Tumors of unknown primary
      • Soft tissue sarcomas
      • Small cell lung cancer
      • Testicular cancer
      • Upper genitourinary tract cancers


  • Patients must have performance status 0-2 by the ECOG scale
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ institutional upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 x ULN
  • Alkaline phosphatase ≤ 2.5 x ULN (if bone metastasis is present in the absence of liver metastasis, alkaline phosphatase must be ≤ 5 x ULN)
  • Creatinine ≤ 1.5 x ULN
  • Patients must not have baseline sensory neuropathy ≥ grade 2
  • Women must not be pregnant or breastfeeding
  • Negative blood or urine pregnancy test
  • Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception


  • Prior treatment is allowed, which may include prior taxane therapy

    • If patient has had prior therapy(ies), s/he must have received last treatment ≥ 28 days prior to registration
  • Patients must not be receiving colony stimulating factors (CSFs)

    • Previous CSFs must have been discontinued > 14 days prior to registration
  • Patients must not be receiving concomitant treatment with any of the following (prior use is allowed, but must have been discontinued ≥ 28 days prior to registration):

    • Phenytoin
    • Carbamazepine
    • Barbiturates
    • Rifampicin
    • Phenobarbital
    • Hypericum perforatum (St. John's wort)
    • Ketoconazole

Information from the National Library of Medicine

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 identifier (NCT number): NCT00499291

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine
Layout table for additonal information Identifier: NCT00499291    
Other Study ID Numbers: CDR0000554709
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Keywords provided by Eastern Cooperative Oncology Group:
unspecified adult solid tumor, protocol specific
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
recurrent bladder cancer
stage III bladder cancer
stage IV bladder cancer
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
clear cell sarcoma of the kidney
rhabdoid tumor of the kidney
recurrent malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
recurrent cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
recurrent endometrial carcinoma
stage III endometrial carcinoma
Additional relevant MeSH terms:
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Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action