Evidence map›Paper›PMID 21472717›Full record

Trial reportCancer2011

A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group Study, N057E(1).

Lisa A Kottschade, Vera J Suman, Thomas Amatruda, Robert R McWilliams, Bassam I Mattar, Daniel A Nikcevich, Robert Behrens, Tom R Fitch, Anthony J Jaslowski, Svetomir N Markovic

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00404235 (A Phase II Trial of Carboplatin), which is not on this map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
3.8field-weighted citation impact, top 6% 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.

NCT00404235 phase2completednot on this map

A Phase II Trial of Carboplatin (CBDCA) and ABI-007(ABX) in Patients With Unresectable Stage IV Melanoma

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2006 to 2010Enrolled76ConditionsMelanoma (Skin)Armscarboplatin, paclitaxel albumin-stabilized nanoparticle formulation
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 96 citations in OpenAlex.

  1. Trial
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  7. Article
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  13. Immunotherapy for Melanoma.Advances in experimental medicine and biology · 2021
    Article
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  15. Review
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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

10 authors at 7 institutions in 1 country.

Lisa A KottschadeMayo Clinic Rochester, Rochester, Minnesota 55905, USA. kottschade.lisa@mayo.edu
Vera J Suman
Thomas Amatruda
Robert R McWilliams
Bassam I Mattar
Daniel A Nikcevich
Robert Behrens
Tom R Fitch
Anthony J Jaslowski
Svetomir N Markovic
Mayo Clinic · USDuluth Clinic · USIowa Oncology Research Association · USMayo Clinic in Arizona · USMetro-Minnesota Community Oncology Research Consortium · USRegional Cancer Center · USWichita Clinic · US

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
SIOUX COMMUNITY CANCER CONSORTIUMU10CA035103 · NCI · UNIVERSITY OF SOUTH DAKOTA · PI MAZURCZAK, MIROSLAW · 1985 to 2014
$11.6M
MISSOURI VALLEY CANCER CONSORTIUM CCOPU10CA063849 · NCI · MISSOURI VALLEY CANCER CONSORTIUM, INC. · PI SOORI, GAMINI · 1994 to 2014
$11.3M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035195 · NCI · CARLE FOUNDATION HOSPITAL (URBANA, IL) · PI ROWLAND, KENDRITH MARTIN · 1985 to 2014
$11.3M
Illinois Oncology Research Association Community Clinical Oncology ProgramU10CA035113 · NCI · ONCOLOGY-HEMATOLOGY ASSOC-CENTRAL ILL · PI LE-LINDQWISTER, NGUYET A. · 1985 to 2014
$10.8M
DULUTH COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035269 · NCI · ESSENTIA INSTITUTE OF RURAL HEALTH · PI NIKCEVICH, DANIEL A · 1985 to 2014
$10.7M
NCI NIH HHS CA-25224NCI NIH HHS CA-35090NCI NIH HHS CA-35101NCI NIH HHS CA-35103NCI NIH HHS CA-35113NCI NIH HHS CA-35195NCI NIH HHS CA-35267NCI NIH HHS CA-35269NCI NIH HHS CA-35415NCI NIH HHS CA-37404NCI NIH HHS CA-37417NCI NIH HHS CA-52352NCI NIH HHS CA-63848NCI NIH HHS CA-63849NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035431NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035101NCI NIH HHS U10 CA035103NCI NIH HHS U10 CA035113NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035195NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035269NCI NIH HHS U10 CA035415NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA037417NCI NIH HHS U10 CA052352NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA063849
6 · The paper itself

Abstract

backgroundThere is increasing evidence that paclitaxel and carboplatin are clinically active in the treatment of metastatic melanoma (MM). ABI-007 is an albumin-bound formulation of paclitaxel that has demonstrated single-agent activity against metastatic melanoma.

methodsA parallel phase II trial was conducted in patients with unresectable stage IV melanoma who were either chemotherapy naive (CN) or previously treated (PT). The treatment regimen consisted of ABI-007 (100 mg/m(2) ) and carboplatin area under the curve (AUC2) administered on days 1, 8, and 15 every 28 days. The primary aim of this study was objective response rate (RECIST).

resultsSeventy-six patients (41 CN and 35 PT) were enrolled between November 2006 and July 2007. Three patients withdrew consent prior to starting treatment. The median number of treatment cycles was 4. There were 10 (25.6%) responses (1 complete response [CR] and 9 partial responses [PRs]) in the CN cohort (90% CI, 16.7%-42.3%) and 3 (8.8%) responses (3 PRs) in the PT cohort (90% CI, 2.5%-21.3%). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. Severe toxicities in both groups (Common Terminology Criteria for Adverse Effects v.3.0 ≥grade 3) included neutropenia, thrombocytopenia, neurosensory problems, fatigue, nausea, and vomiting.

conclusionsThe weekly combination of ABI-007 and carboplatin appears to be moderately well tolerated, with promising clinical activity as therapy in patients who are chemotherapy naive and with modest antitumor activity in those previously treated.

Indexed as

AdultAgedAged, 80 and overAlbumin-Bound PaclitaxelAlbuminsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCohort StudiesDrug Administration ScheduleFemaleHumansMaleMelanomaMiddle AgedPaclitaxelSkin NeoplasmsAlbumin-Bound PaclitaxelAlbuminsCarboplatinPaclitaxel

Identifiers

PMID21472717
PMCPMC3116030
OpenAlexW2019006921

What OpenQuestion holds

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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.