NCT00499291

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

First QC Date

July 10, 2007

Last Update Submit

May 23, 2023

Conditions

Cancer

Keywords

unspecified adult solid tumor, protocol specificrecurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerrecurrent prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerextensive stage small cell lung cancerrecurrent small cell lung cancerrecurrent bladder cancerstage III bladder cancerstage IV bladder cancerrecurrent renal cell cancerstage III renal cell cancerstage IV renal cell cancerclear cell sarcoma of the kidneyrhabdoid tumor of the kidneyrecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorrecurrent cervical cancerstage III cervical cancerstage IVA cervical cancerstage IVB cervical cancerrecurrent endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomafallopian tube cancerrecurrent ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian germ cell tumorstage III ovarian germ cell tumorstage IV ovarian germ cell tumorovarian sarcomaovarian stromal cancerrecurrent uterine sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent hypopharyngeal cancerstage III hypopharyngeal cancerstage IV hypopharyngeal cancerrecurrent laryngeal cancerstage III laryngeal cancerstage IV laryngeal cancerrecurrent lip and oral cavity cancerstage III lip and oral cavity cancerstage IV lip and oral cavity cancerrecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primaryrecurrent nasopharyngeal cancerstage III nasopharyngeal cancerstage IV nasopharyngeal cancerrecurrent oropharyngeal cancerstage III oropharyngeal cancerstage IV oropharyngeal cancerrecurrent paranasal sinus and nasal cavity cancerstage III paranasal sinus and nasal cavity cancerstage IV paranasal sinus and nasal cavity cancerrecurrent salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent esophageal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent gastric cancerstage III gastric cancerstage IV gastric canceradult central nervous system germ cell tumoradult teratomaovarian teratomatesticular teratomarecurrent adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomarecurrent carcinoma of unknown primary

Outcome Measures

Primary Outcomes (1)

  • Inter-individual pharmacokinetic variability

Secondary Outcomes (4)

  • Pharmacokinetic parameters

  • Neutropenia

  • CYP2C8*3 variant expression

  • Genetic variance relating to pharmacokinetics and toxicity

Interventions

paclitaxel albumin-stabilized nanoparticle formulationDRUG
gene expression analysisPROCEDURE
laboratory biomarker analysisPROCEDURE
pharmacological studyPROCEDURE
polymerase chain reactionPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsProstatic NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaUrinary Bladder NeoplasmsCarcinoma, Renal CellTesticular NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsCarcinoma, Ovarian EpithelialHypopharyngeal NeoplasmsLaryngeal NeoplasmsMouth NeoplasmsNasopharyngeal NeoplasmsOropharyngeal NeoplasmsSalivary Gland NeoplasmsEsophageal NeoplasmsStomach NeoplasmsTeratomaTeratoma, OvarianTeratoma, TesticularSarcomaNeoplasms, Unknown Primary

Interventions

TaxesGene Expression ProfilingPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsKidney DiseasesEndocrine Gland NeoplasmsEndocrine System DiseasesTesticular DiseasesGonadal DisordersUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFallopian Tube DiseasesAdnexal DiseasesOvarian NeoplasmsOvarian DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesMouth DiseasesNasopharyngeal DiseasesSalivary Gland DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesNeoplasms, Germ Cell and EmbryonalNeoplasms, Connective and Soft TissueNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsGenetic TechniquesInvestigative TechniquesNucleic Acid Amplification Techniques

Study Officials

  • Sridhar Mani, MD

    Albert Einstein College of Medicine

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

September 1, 2006

Last Updated

May 25, 2023

Record last verified: 2023-05