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CompletedNCT00095914Updated Mar 15, 2012

Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1 interventional study of paclitaxel and paclitaxel albumin-stabilized nanoparticle formulation in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-15.

Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel.

Secondary

  • Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients.
  • Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients.
  • Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen.

OUTLINE: This is a randomized, pilot study.

  • Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22.
    • Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22.
  • Courses 3 and beyond: All patients receive ABI-007 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

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Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant solid tumor

    • Considered incurable
    • Locally advanced or metastatic disease
  • Likely to be responsive to taxane-based therapy

    • Patients who are refractory to prior paclitaxel are ineligible
  • No symptomatic or untreated brain metastasis or carcinomatous meningitis

    • No patients who are unable to remain free of corticosteroid therapy for > 4 weeks due to CNS disease
  • No previously untreated locally advanced breast cancer
  • No hematologic malignancy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3

Hepatic

  • Bilirubin normal
  • ALT and AST ≤ 1.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • LVEF ≥ 40%
  • No clinical signs or symptoms of heart failure
  • No symptomatic congestive heart failure
  • No unstable angina pectoris

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to paclitaxel (e.g., docetaxel, Cremophor\^® EL [CrEL], polysorbate 80 [Tween 80], or CrEL-containing medications [e.g., cyclosporine])
  • No history of seizure disorder requiring anticonvulsant therapy
  • No active serious infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy
  • No concurrent filgrastim (G-CSF) during courses 1 and 2

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 2 weeks since prior hormonal therapy
  • Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed

Radiotherapy

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 2 weeks since prior drugs, herbal preparations, or dietary supplements known to influence CYP3A4 (e.g., phenytoin, rifampin, Hypericum perforatum [St. John's wort], garlic supplements, or grapefruit juice) and/or CYP2C8
  • No concurrent substances known or likely to interfere with the pharmacokinetics of paclitaxel (e.g., verapamil or cyclosporine)
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • Drugpaclitaxel
  • Drugpaclitaxel albumin-stabilized nanoparticle formulation
06

Study locations

1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00095914
Lead sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
First posted
Nov 9, 2004
Start date
Sep 2004
Primary completion
May 2007
Completion
Mar 2009
Last update
Mar 15, 2012

Study contacts

William D. Figg, PharmD
study chair · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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