Evidence map›Paper›PMID 23419134›Full record

Trial reportBJU international2013

Phase II clinical trial of cediranib in patients with metastatic castration-resistant prostate cancer.

William L Dahut, Ravi A Madan, Joyson J Karakunnel, David Adelberg, James L Gulley, Ismail B Turkbey, Cindy H Chau, Shawn D Spencer, Marcia Mulquin, John Wright and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BJU international, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00436956 (A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 5% 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.

NCT00436956 phase2completednot on this map

A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2006 to 2014Enrolled59ConditionsProstate CancerArmsMagnetic Resonance Imaging (DCE-MRI), AZD2171, Prednisone
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Magnetic Resonance Imaging for Drug Development.Advances in experimental medicine and biology · 2021
    Article
  8. Targeting treatment options for castration-resistant prostate cancer.American journal of clinical and experimental urology · 2021
    Review
  9. Article
  10. PARP inhibitor combinations in prostate cancer.Therapeutic advances in medical oncology · 2020
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. MR Imaging Biomarkers in Oncology Clinical Trials.Magnetic resonance imaging clinics of North America · 2016
    Review
  17. Article
  18. Review
  19. Article
  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

14 authors at 2 institutions in 1 country.

William L DahutMedical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Ravi A Madan
Joyson J Karakunnel
David Adelberg
James L Gulley
Ismail B Turkbey
Cindy H Chau
Shawn D Spencer
Marcia Mulquin
John Wright
Howard L Parnes
Seth M Steinberg
Peter L Choyke
William D Figg
National Cancer Institute · USCenter for Cancer Research · US

Funding

Prostate Cancer ImagingZIABC010655 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CHOYKE, PETER L · 2009 to 2025
$49.2M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZICSC006537 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$14.4M
Drug Development for Prostate Cancer and other Metastatic ProcessesZIABC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$10.2M
Development of Anticancer AgentsZIASC006538 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$8.6M
The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZIASC010098 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2009 to 2022
$7.6M
Development of Drugs That Target Prostate CancerZ01BC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2003 to 2008
$463k
Combination Studies in Prostat CancerZIABC011521 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI MADAN, RAVI · 2013 to 2013
$76k
CCR NIH HHS HHSN261200800001CIntramural NIH HHS Z01 BC010547NCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

objectiveTo assess the efficacy and toxicity of cediranib, a highly potent inhibitor of vascular endothelial growth factor receptor tyrosine kinases, in patients with metastatic castration-resistant prostate cancer (CRPC) previously treated with docetaxel-based therapy. PATIENTS AND

methodsThe study used a Simon two-stage trial design, which required at least two of 12 patients in the first cohort to be progression-free at 6 months. We enrolled a total of 35 evaluable patients who all received cediranib 20 mg orally daily. In a second cohort, 23 additional patients received prednisone 10 mg daily with cediranib. Endpoints included tumour response, progression-free survival (PFS), overall survival (OS), vascular permeability via dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), and toxicity.

resultsA total of 59 patients were enrolled, of whom 67% had received two or more previous chemotherapy regimens. Six of 39 patients with measurable disease had confirmed partial responses and one had an unconfirmed partial response. At 6 months, 43.9% of patients were progression-free; the median PFS and OS periods for all patients were 3.7 months and 10.1 months, respectively. We found that the DCE-MRI variables baseline transport constant (Ktrans ) and rate constant at day 28 were significantly associated with PFS in univariate analyses, but only baseline Ktrans remained significant when considered jointly. The most frequent toxicities were hypertension, fatigue, anorexia and weight loss; the addition of prednisone reduced the incidence of constitutional toxicities.

conclusionThis study demonstrated that cediranib was generally well tolerated with some anti-tumour activity in highly pretreated patients with metastatic CRPC who had progressive disease after docetaxel-based therapy.

Indexed as

OrchiectomyAdenocarcinomaAdministration, OralAgedDose-Response Relationship, DrugFollow-Up StudiesHumansIndolesMagnetic Resonance ImagingMaleMiddle AgedNeoplasm MetastasisProstatic NeoplasmsProtein Kinase InhibitorsQuinazolinesTime FactorscediranibIndolesProtein Kinase InhibitorsQuinazolines

Identifiers

PMID23419134
PMCPMC3660464
OpenAlexW1518547144

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.