Evidence map›Paper›PMID 19565187›Full record

Trial reportInvestigational new drugs2010

Phase II study of darinaparsin in patients with advanced hepatocellular carcinoma.

Jennifer Wu, Charles Henderson, Lynn Feun, Peter Van Veldhuizen, Philip Gold, Hui Zheng, Theresa Ryan, Lawrence S Blaszkowsky, Haobin Chen, Max Costa and 7 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–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.

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

20 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Mechanisms of Multidrug Resistance in Cancer Chemotherapy.International journal of molecular sciences · 2020
    Review
  7. Review
  8. Article
  9. Article
  10. The elements of life and medicines.Philosophical transactions. Series A, Mathematical, physical, and engineering sciences · 2015
    Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Yin-yang and Zheng: Exported from Chinese medicine.Chinese journal of integrative medicine · 2014 · on this map
    Article
  16. Review
  17. Darinaparsin: solid tumor hypoxic cytotoxin and radiosensitizer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012
    Article
  18. Review
  19. Review
  20. 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

17 authors.

Jennifer WuDepartment of Medical Oncology, NYU School of Medicine, New York, NY, USA. Jennifer.wu@nyumc.org
Charles Henderson
Lynn Feun
Peter Van Veldhuizen
Philip Gold
Hui Zheng
Theresa Ryan
Lawrence S Blaszkowsky
Haobin Chen
Max Costa
Barry Rosenzweig
MaryLynn Nierodzik
Howard Hochster
Franco Muggia
Giovanni Abbadessa
Jonathan Lewis
Andrew X Zhu

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDarinaparsin is a novel organic arsenic that reaches higher intracellular concentration with decreased toxicity compared to inorganic arsenic. We conducted a multi-center phase II study with darinaparsin in patients with advanced HCC.

methodsEligibility criteria included unresectable or metastatic measurable HCC, up to two prior systemic treatments, ECOG performance status < or = 2, Child Pugh Class A or B and adequate organ functions. Darinaparsin was administered at 420 mg/m(2) intravenously, twice weekly at least 72 h apart for 3 weeks in a 4-week cycle. The primary end point was response rate. A Simon two-stage design was used.

resultsAmong 15 patients in the first stage, no objective responses were observed. Two patients had stable disease. The median number of cycles on study per patient was 2 (1-6). The median progression free survival and overall survival were 55 days (95% confidence interval: 50-59) and 190 days (95% confidence interval: 93-227), respectively. No treatment related hospitalizations or deaths occurred. Treatment related grade 1-2 toxicities included nausea, vomiting (26.7% each), fatigue (20%), anorexia and diarrhea (13.3% each). Grade 3 anorexia, wheezing, agitation, abdominal pain and SGPT were observed in 1 patient each (6.7%). One patient experienced grade 4 hypoglycemia (6.7%).

conclusionsDarinaparsin could be safely administered with tolerable toxicity profiles, and no QTc prolongation in patients with advanced HCC. However, at this dose and schedule, it has shown no objective responses in HCC and this trial was terminated as planned after the first stage of efficacy analysis.

Indexed as

AdultAgedAntineoplastic AgentsArsenicalsCarcinoma, HepatocellularDisease-Free SurvivalFemaleGlutathioneHumansLiver NeoplasmsMaleMiddle AgedNeoplasm StagingTreatment OutcomeAntineoplastic AgentsArsenicalsdarinaparsinGlutathione

Identifiers

What OpenQuestion holds

Textmetadata
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.