- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00499291
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors
Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel (Nanoparticle Albumin Bound-Paclitaxel) in Patients With Advanced Solid Tumors
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
- 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 CONCURRENT THERAPY:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Inter-individual pharmacokinetic variability
|
Secondary Outcome Measures
Outcome Measure |
---|
Pharmacokinetic parameters
|
Neutropenia
|
CYP2C8*3 variant expression
|
Genetic variance relating to pharmacokinetics and toxicity
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Sridhar Mani, MD, Albert Einstein College Of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV renal cell cancer
- recurrent renal cell cancer
- stage III malignant testicular germ cell tumor
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- stage III bladder cancer
- recurrent bladder cancer
- stage IV bladder cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- unspecified adult solid tumor, protocol specific
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- stage IIIC breast cancer
- fallopian tube cancer
- adult central nervous system germ cell tumor
- stage IV gastric cancer
- recurrent gastric cancer
- stage IV endometrial carcinoma
- recurrent endometrial carcinoma
- stage III renal cell cancer
- stage III cervical cancer
- stage IVA cervical cancer
- stage III gastric cancer
- stage III esophageal cancer
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- ovarian sarcoma
- recurrent esophageal cancer
- recurrent cervical cancer
- stage IVB cervical cancer
- stage III uterine sarcoma
- ovarian stromal cancer
- recurrent ovarian germ cell tumor
- stage III ovarian germ cell tumor
- stage IV ovarian germ cell tumor
- recurrent malignant testicular germ cell tumor
- stage III endometrial carcinoma
- stage IV esophageal cancer
- stage III adult soft tissue sarcoma
- recurrent carcinoma of unknown primary
- clear cell sarcoma of the kidney
- rhabdoid tumor of the kidney
- recurrent hypopharyngeal cancer
- stage III hypopharyngeal cancer
- stage IV hypopharyngeal cancer
- recurrent laryngeal cancer
- stage III laryngeal cancer
- stage IV laryngeal cancer
- recurrent lip and oral cavity cancer
- stage III lip and oral cavity cancer
- stage IV lip and oral cavity cancer
- recurrent nasopharyngeal cancer
- stage III nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- recurrent oropharyngeal cancer
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- recurrent paranasal sinus and nasal cavity cancer
- stage III paranasal sinus and nasal cavity cancer
- stage IV paranasal sinus and nasal cavity cancer
- adult teratoma
- ovarian teratoma
- testicular teratoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000554709
- ECOG-E1Y06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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