CancerNCT00499291
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors
A study testing paclitaxel albumin-stabilized nanoparticle formulation, gene expression analysis and laboratory biomarker analysis in people with Cancer, run by Eastern Cooperative Oncology Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer
- What is being tested?
- paclitaxel albumin-stabilized nanoparticle formulation, gene expression analysis and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- paclitaxel albumin-stabilized nanoparticle formulation, gene expression analysis, laboratory biomarker analysis, pharmacological study, polymerase chain reaction
- Keywords
- 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
- Medical subject headings
- Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Urinary Bladder Neoplasms, Carcinoma, Renal Cell, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel albumin-stabilized nanoparticle formulationDrug
gene expression analysisProcedure or surgery
laboratory biomarker analysisProcedure or surgery
pharmacological studyProcedure or surgery
polymerase chain reactionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-individual pharmacokinetic variability
Secondary outcomes (4)
Pharmacokinetic parameters
Neutropenia
CYP2C8*3 variant expression
Genetic variance relating to pharmacokinetics and toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sridhar Mani, MD, Study chair, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499291
- Sponsor's protocol ID
- CDR0000554709
- Other IDs
- ECOG-E1Y06
- Status last verified
- May 2023
- First submitted
- 10 Jul 2007
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel (Nanoparticle Albumin Bound-Paclitaxel) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00499291
- Acronym / sponsor ID
- CDR0000554709
- Conditions
- Cancer
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2006
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | – |
| gene expression analysis | Procedure or surgery | – |
| laboratory biomarker analysis | Procedure or surgery | – |
| pharmacological study | Procedure or surgery | – |
| polymerase chain reaction | Procedure or surgery | – |
Primary outcome
Inter-individual pharmacokinetic variability
4 secondary outcomes
Pharmacokinetic parameters
Neutropenia
CYP2C8*3 variant expression
Genetic variance relating to pharmacokinetics and toxicity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sridhar Mani, MD study chair
Albert Einstein College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing paclitaxel albumin-stabilized nanoparticle formulation, gene expression analysis and laboratory biomarker analysis in people with Cancer, run by Eastern Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-individual pharmacokinetic variability. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.