Evidence map›Paper›PMID 25740387›Full record

Trial reportCancer2015

Three-arm, randomized, phase 2 study of carboplatin and paclitaxel in combination with cetuximab, cixutumumab, or both for advanced non-small cell lung cancer (NSCLC) patients who will not receive bevacizumab-based therapy: An Eastern Cooperative Oncology Group (ECOG) study (E4508).

Nasser H Hanna, Suzanne E Dahlberg, Jill M Kolesar, Charu Aggarwal, Fred R Hirsch, Suresh S Ramalingam, Joan H Schiller

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Implications of Insulin-like Growth Factor 1 Receptor Activation in Lung Cancer.The Malaysian journal of medical sciences : MJMS · 2016
    Review
  11. Review
  12. Article
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

7 authors at 7 institutions in 1 country.

Nasser H HannaIndiana University Health Simon Cancer Center, Indianapolis, Indiana.
Suzanne E DahlbergDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Jill M KolesarSchool of Pharmacy, University of Wisconsin, Madison, Wisconsin.
Charu AggarwalAbramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.
Fred R HirschSchool of Medicine, Division of Medical Oncology, University of Colorado, Denver, Colorado.
Suresh S RamalingamWinship Cancer Institute of Emory University, Atlanta, Georgia.
Joan H SchillerHematology/Oncology Division, University of Texas Southwestern Medical Center, Dallas, Texas.
Dana-Farber Cancer Institute · USEmory University · USIndiana University – Purdue University Indianapolis · USThe University of Texas Southwestern Medical Center · USUniversity of Colorado Denver · USUniversity of Pennsylvania · USUniversity of Wisconsin–Madison · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
EASTERN COOPERATIVE ONCOLOGY GROUP--WISCONSIN STUDIESU10CA021076 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI KAHL, BRAD · 1985 to 2013
$8.2M
ONCOLOGYU10CA015488 · NCI · UNIVERSITY OF PENNSYLVANIA · PI LUGER, SELINA M · 1985 to 2013
$5.6M
ONCOLOGYU10CA049883 · NCI · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI MILLER, KATHY D. · 1989 to 2013
$4.0M
University of Colorado NTCN Lead Academic Participating Site (LAPS) U10CA180834 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 2014 to 2018
$3.8M
UT Southwestern NCI National Clinical Trials Network Lead Academic Site - U10U10CA180870 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI GERBER, DAVID ERIC · 2014 to 2018
$3.4M
Winship Cancer Institute, National Clinical Trials Network Lead Academic ParticipU10CA180864 · NCI · EMORY UNIVERSITY · PI BEITLER, JONATHAN, RAMALINGAM, SURESH S · 2014 to 2018
$2.9M
NCI NIH HHS CA180794NCI NIH HHS CA180795NCI NIH HHS CA180799NCI NIH HHS CA180820NCI NIH HHS CA180834NCI NIH HHS CA180864NCI NIH HHS CA180870NCI NIH HHS U10 CA015488NCI NIH HHS U10 CA021076NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA049883NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180795NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180864NCI NIH HHS U10 CA180870NCI NIH HHS U24 CA196172
6 · The paper itself

Abstract

backgroundPreclinical evidence supports the clinical investigation of inhibitors to the insulin-like growth factor receptor (IGFR) and the epidermal growth factor receptor (EGFR) either alone or in combination as treatment for patients with non-small cell lung cancer (NSCLC).

methodsPatients with chemotherapy-naïve, advanced NSCLC who had an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Patients were randomized to receive carboplatin intravenously at an area under the plasma drug concentration-time curve of 6.0 plus paclitaxel 200 mg/m(2) intravenously on day 1 every 3 weeks combined with either intravenous cetuximab weekly (arm A), intravenous cixutumumab every 2 weeks (arm B), or both (arm C). Patients who had nonprogessing disease after 12 weeks of therapy were permitted to continue on maintenance antibody therapy until they developed progressive disease. The primary endpoint was progression-free survival (PFS). The study design required 180 eligible patients and had 88% power to detect a 60% increase in median PFS for either comparison (arm A vs arm C or arm B vs arm C) using the log-rank test.

resultsFrom September 2009 to December 2010, 140 patients were accrued. The study was closed to accrual early because of an excessive number of grade 5 events reported on arms A and C. Thirteen patients died during treatment (6 patients on arm A, 2 patients on arm B, and 5 patients on arm C), including 9 within approximately 1 month of starting therapy. The estimated median PFS for arms A, B, and C were similar at 3.4 months, 4.2 months, and 4 months, respectively.

conclusionsOn the basis of the apparent lack of efficacy and excessive premature deaths, the current results do not support the continued investigation of carboplatin, paclitaxel, and cixutumumab either alone or in combination with cetuximab for patients with advanced NSCLC.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungCetuximabFemaleHumansLung NeoplasmsMaleMiddle AgedPaclitaxelAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabCarboplatinCetuximabcixutumumabPaclitaxelcarboplatincetuximabcixutumumabnon-small cell lung cancerpaclitaxel

Identifiers

PMID25740387
PMCPMC4560671
OpenAlexW2128649135

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.