Evidence map›Paper›PMID 18594000›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008

Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel.

Erin R Gardner, William L Dahut, Charity D Scripture, Jacquin Jones, Jeanny B Aragon-Ching, Neil Desai, Michael J Hawkins, Alex Sparreboom, William D Figg

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04524299 (A Phase II,Randomized Controlled Clinical Trial of Staged Thoracic Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin Twice a Week for Locally Advanced NSCLC), which is not on this map. Cited by 111 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04524299 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

A Phase II,Randomized Controlled Clinical Trial of Staged Thoracic Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin Twice a Week for Locally Advanced NSCLC

TypeinterventionalSponsorSun Yat-sen UniversityRan2020 to 2024Enrolled160ConditionsNon-small Cell Lung CancerArmschest radiation(IMRT), Concurrent chemotherapy twice a week, Concurrent chemotherapy once a week
3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 2 syntheses or guidelines pooled it, 218 citations in OpenAlex.

  1. Pooled it
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  7. Clinical and Biomarker Results from Phase I/II Study of PI3K Inhibitor Alpelisib plus Nab-paclitaxel in HER2-Negative Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
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  14. Nanoparticles: An Emerging Hope in Cancer Therapy.Nanomaterials (Basel, Switzerland) · 2026
    Review
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51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Erin R GardnerClinical Pharmacology Program, Science Applications International Corporation-Frederick, Inc., National Cancer Institute-Frederick, Frederick, Maryland, USA.
William L Dahut
Charity D Scripture
Jacquin Jones
Jeanny B Aragon-Ching
Neil Desai
Michael J Hawkins
Alex Sparreboom
William D Figg
Center for Cancer Research · USNational Cancer Institute · USAbraxis (United States) · USScience Applications International Corporation (United States) · US

Funding

The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZIASC010098 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2009 to 2022
$7.6M
The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZ01SC010098 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2000 to 2008
$1.1M
Pharmacokinetic and Pharmacodynamic Modeling of Anticancer AgentsZ01BC010548 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2003 to 2008
$815k
Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZ01SC006537 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 1997 to 2008
$379k
Intramural NIH HHS NIH0011335962Intramural NIH HHS Z01 BC010548Intramural NIH HHS Z01 SC006537Intramural NIH HHS Z01 SC010098NCI NIH HHS N01 CO012400
6 · The paper itself

Abstract

purposeAbraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug. PATIENTS AND

methodsPatients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab-paclitaxel (260 mg/m(2) as a 30-minute infusion) or sb-paclitaxel (175 mg/m(2) as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab-paclitaxel.

resultsSeventeen patients were treated, with 14 receiving at least one cycle each of nab-paclitaxel and sb-paclitaxel. No change in nab-paclitaxel pharmacokinetics was found between the first and second cycles (P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations (P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab-paclitaxel administration, due to the increased free fraction (0.063 +/- 0.021 versus 0.024 +/- 0.009; P < 0.001).

conclusionThis study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab-paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel.

Indexed as

AdultAgedAlbuminsAntineoplastic Agents, PhytogenicBreast NeoplasmsCarcinomaCross-Over StudiesFallopian Tube NeoplasmsFemaleHumansMaleMiddle AgedOvarian NeoplasmsPaclitaxelProstatic NeoplasmsSolvents130-nm albumin-bound paclitaxelAlbuminsAntineoplastic Agents, PhytogenicPaclitaxelSolvents

Identifiers

PMID18594000
PMCPMC2661025
OpenAlexW2060597541

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.