Evidence map›Paper›PMID 37104870›Full record

Trial reportThe oncologist2023

Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial.

Shannon Stockton, Paul Catalano, Steven J Cohen, Barbara A Burtness, Edith P Mitchell, Efrat Dotan, Sam J Lubner, Pankaj Kumar, Mary F Mulcahy, George A Fisher and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01142388 (Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% 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.

NCT01142388 phase2active not recruitingnot on this map

Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2010 to 2027Enrolled94ConditionsMetastatic Esophageal Adenocarcinoma, Metastatic Esophageal Squamous Cell Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Recurrent Esophageal AdenocarcinomaArmsCixutumumab, Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Review
  2. Review
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

12 authors at 11 institutions in 1 country.

Shannon StocktonDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID 0000-0003-2799-663X
Paul CatalanoDana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA, USA.
Steven J CohenJefferson Health System/Abington Memorial Hospital, Abington, PA, USA.
Barbara A BurtnessYale University, New Haven, CT, USA.
Edith P MitchellThomas Jefferson University, Philadelphia, PA, USA.
Efrat DotanFox Chase Cancer Center, Philadelphia, PA, USA.ORCID 0000-0002-5762-512X
Sam J LubnerUniversity of Wisconsin, Madison, WI, USA.
Pankaj KumarIllinois CancerCare, Peoria, IL, USA.
Mary F MulcahyNorthwestern University, Evanston, IL, USA.
George A FisherStanford Cancer Center, Stanford University, Palo Alto, CA, USA.
Theodore L CrandallUniversity of Pittsburgh, Pittsburgh, PA, USA.
Al BensonNorthwestern University, Evanston, IL, USA.
Northwestern University · USAbington Memorial Hospital · USDana-Farber Cancer Institute · USFox Chase Cancer Center · USIllinois CancerCare · USStanford University · USThomas Jefferson University · USUniversity of Pittsburgh · USUniversity of Wisconsin–Madison · USVanderbilt University Medical Center · USYale University · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Northwestern University Lead Academic Participating Site Supplement Year 2UG1CA233320 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B, MATEI, DANIELA E · 2019 to 2025
$5.5M
National Clinical Trials Network Research at the University of WisconsinUG1CA233277 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Lisa M Barroilhet, Andrew M. Baschnagel · 2019 to 2026
$4.9M
NCI NCTN-Network Lead Academic Site at UPCIU10CA180844 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BRUFSKY, ADAM M, EDWARDS, ROBERT PAGE · 2014 to 2018
$4.5M
Sidney Kimmel Cancer Center LAPS Institutional CollaborationUG1CA233341 · NCI · THOMAS JEFFERSON UNIVERSITY · PI Steven Cohen, Mitchell Edelson · 2019 to 2026
$3.5M
Vanderbilt Network Lead Academic Participating Site for the NCTNUG1CA233270 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Kristen Keon Ciombor · 2019 to 2026
$3.5M
Yale Cancer Center NCTNU10CA180826 · NCI · YALE UNIVERSITY · PI FUCHS, CHARLES S · 2014 to 2018
$3.4M
National Clinical Trials Network Research at the University of WisconsinU10CA180799 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ANDERSON, BETHANY M, KUSHNER, DAVID M · 2014 to 2018
$2.8M
NCATS NIH HHS UL1 TR001863NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180826NCI NIH HHS U10 CA180844NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA233270NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233341
6 · The paper itself

Abstract

backgroundPatients with advanced esophageal cancer carry poor prognoses; limited data exist to guide second-line therapy in the metastatic setting. Paclitaxel has been used yet is associated with limited efficacy. There is preclinical evidence of synergy between paclitaxel and cixutumumab, a monoclonal antibody targeting insulin-like growth factor-1 receptor. We conducted a randomized phase II trial of paclitaxel (arm A) versus paclitaxel plus cixutumumab (arm B) in the second-line for patients with metastatic esophageal or gastroesophageal junction (GEJ) cancers.

methodsThe primary endpoint was progression-free survival (PFS); 87 patients (43 in arm A, 44 in arm B) were treated.

resultsMedian PFS was 2.6 months in arm A [90% CL 1.8-3.5] and 2.3 months in arm B [90% 2.0-3.5], P = .86. Stable disease was observed in 29 (33%) patients. Objective response rates for Arms A and B were 12% [90% CI, 5-23%] and 14% [90% CI, 6-25%]. Median overall survival was 6.7 months [90% CL 4.9-9.5] in arm A and 7.2 months [90% CL 4.9-8.1] in arm B, P = 56.

conclusionThe addition of cixutumumab to paclitaxel in second-line therapy of metastatic esophageal/GEJ cancer was well tolerated but did not improve clinical outcomes relative to standard of care (ClinicalTrials.gov Identifier: NCT01142388).

Indexed as

Esophageal NeoplasmsStomach NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEsophagogastric JunctionHumansPaclitaxelAntibodies, Monoclonal, HumanizedcixutumumabPaclitaxelesophagealgastroesophageal junctioninsulin-like growth factor-1 receptorxixutumumab

Identifiers

PMID37104870
PMCPMC10485278
OpenAlexW4367187125

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.