Evidence map›Paper›PMID 30309721›Full record

Trial reportGynecologic oncology2018

A phase II evaluation of elesclomol sodium and weekly paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer: An NRG oncology/gynecologic oncology group study.

Bradley J Monk, James T Kauderer, Katherine M Moxley, Albert J Bonebrake, Summer B Dewdney, Angeles Alvarez Secord, Frederick R Ueland, Carolyn M Johnston, Carol Aghajanian

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00888615 (A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer), which is not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00888615 phase2completednot on this map

A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

TypeinterventionalSponsorGOG FoundationRan2010 to 2016Enrolled58ConditionsFallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous AdenocarcinomaArmsElesclomol Sodium, Paclitaxel
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. The Role of Oxidative Stress in Peripheral Neuropathy.Journal of molecular neuroscience : MN · 2020
    Pooled it
  2. Trial
  3. Review
  4. Review
  5. Role of Ferredoxin 1Cancer pathogenesis and therapy · 2026
    Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Role ofJournal of thoracic disease · 2025
    Article
  16. Article
  17. Review
  18. Targeting copper homeostasis:Acta pharmaceutica Sinica. B · 2025
    Article
  19. Review
  20. 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

9 authors.

Bradley J MonkArizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph Hospital, Phoenix, AZ, USA. Electronic address: Bradley.Monk@usoncology.com.
James T KaudererNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park, Buffalo, NY, USA. Electronic address: jkauderer@gogstats.org.
Katherine M MoxleyUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Electronic address: katherine-moxley@ouhsc.edu.
Albert J BonebrakeCancer Research for the Ozarks-Cox Health. Ferrell Duncan Clinic GYN-ONC, Springfield, MO 65807, USA. Electronic address: albert.bonebrake@coxhealth.com.
Summer B DewdneyRush University Medical Center, Chicago, IL 60612, USA. Electronic address: summer_dewdney@rush.edu.
Angeles Alvarez SecordDuke University Medical Center, Duke Cancer Institute, Durham, NC, USA. Electronic address: angeles.secord@duke.edu.
Frederick R UelandUniversity of Kentucky, Lexington, KY 40536, USA. Electronic address: fuela0@uky.edu.
Carolyn M JohnstonUniversity of Michigan Health System-Cancer Center, Ann Arbor, MI, USA. Electronic address: johnstob@med.umich.edu.
Carol AghajanianMemorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY, USA. Electronic address: aghajanc@mskcc.org.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

objectivePreclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal or peritoneal cancer through the frequency of objective tumor responses (ORR).

methodsPatients with measurable disease, acceptable organ function, performance status ≤ 2, and one prior platinum containing regimen were eligible. A two-stage design was utilized with a target sample size of 22 and 30 subjects, respectively. Prior Gynecologic Oncology Group studies within the same population involving single agent taxanes showed an ORR of approximately (20%) and served as a historical control for direct comparison. The present study was designed to determine if the regimen had an ORR of ≥40% with 90% power.

resultsFifty-eight patients were enrolled, of whom 2 received no study treatment and were inevaluable. The median number of cycles was 3 (268 total cycles, range 1-18). The number of patients responding was 11 (19.6%; 90% CI 11.4% to 30.4%) with one complete response. The median progression-free survival and overall survival was 3.6 months and 13.3 months, respectively. The median ORR duration was 9.2 months. Percentages of subjects with grade 3 toxicity included: Neutropenia 9%; anemia 5%; metabolic 5%; nausea 4%; infection 4%; neurologic (mostly neuropathy) 4%; and vascular (mostly thromboembolism) 4%. There were no grade 4 toxicities reported.

conclusionsThis combination was well tolerated but is unworthy of further investigation based on the proportion responding [ClinicalTrials.gov Identifier: NCT00888615].

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsFallopian Tube NeoplasmsFemaleHumansHydrazinesMiddle AgedOvarian NeoplasmsPaclitaxelPeritoneal NeoplasmsAntineoplastic Agents, PhytogenicelesclomolHydrazinesPaclitaxelClinical trialElesclomolOvarian cancer

Identifiers

PMID30309721
PMCPMC6392076

What OpenQuestion holds

Textmetadata
LicenceTDM
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.