Clinical trial · Interventional

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

NCT00499291CI-TRIAL-00066691withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
gene expression analysis	Procedure	—	UNRESOLVED
laboratory biomarker analysis	Procedure	—	UNRESOLVED
paclitaxel albumin-stabilized nanoparticle formulation	Drug	Nab-paclitaxel	ALIAS
pharmacological study	Procedure	—	UNRESOLVED
polymerase chain reaction	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Inter-individual pharmacokinetic variability

Secondary outcomes (4)

measure
Pharmacokinetic parameters
measure
Neutropenia
measure
CYP2C8*3 variant expression
measure
Genetic variance relating to pharmacokinetics and toxicity

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment