Evidence map›Paper›PMID 20336348›Full record

Trial reportInvestigational new drugs2011

Cilengitide (EMD 121974, NSC 707544) in asymptomatic metastatic castration resistant prostate cancer patients: a randomized phase II trial by the prostate cancer clinical trials consortium.

Deborah A Bradley, Stephanie Daignault, Charles J Ryan, Robert S Dipaola, Kathleen A Cooney, David C Smith, Eric Small, Paul Mathew, Mitchell E Gross, Mark N Stein and 7 more

Erratum issuedAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Investigational new drugs, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
5.8field-weighted citation impact, top 4% 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

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. TGF-β signaling in health, disease, and therapeutics.Signal transduction and targeted therapy · 2024
    Review
  5. Targeting TGFβ signal transduction for cancer therapy.Signal transduction and targeted therapy · 2021
    Review
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  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
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  18. Review
  19. The effect of cilengitide in combination with irradiation and chemotherapy in head and neck squamous cell carcinoma cell lines.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2014
    Article
  20. Article
4 · The record

Corrections and comments

  • Erratum issued
    Cooney, Kathleen A [added]; Mathew, Paul [added]; Pienta, Kenneth J [added]; Escara-Wilke, June [added]; Doyle, Gerald [added]; Al-Hawary, Mahmoud [added]; Keller, Evan T [added]
5 · Who and what money

Authors and funding

17 authors at 5 institutions in 1 country.

Deborah A BradleyDuke University, Durham, NC, USA [corrected].
Stephanie Daignault
Charles J Ryan
Robert S Dipaola
Kathleen A Cooney
David C Smith
Eric Small
Paul Mathew
Mitchell E Gross
Mark N Stein
Alice Chen
Kenneth J Pienta
June Escara-Wilke
Gerald Doyle
Mahmoud Al-Hawary
Evan T Keller
Maha Hussain
University of Michigan–Ann Arbor · USCancer Institute of Florida · USUniversity of California, San Francisco · USCedars-Sinai Medical Center · USDuke University · US

Funding

VACCINIA PSA FOR ANDROGEN-MODULATED POST-SURGICAL RECURRENCE OF PROSTATE CANCERP50CA069568 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI COONEY, KATHLEEN A · 1995 to 2013
$31.3M
NCI NIH HHS P50 CA069568
6 · The paper itself

Abstract

backgroundIntegrins are involved in prostate cancer metastasis by regulating cell adhesion, migration, invasion, motility, angiogenesis and bone metabolism. We evaluated the efficacy of two dose levels of cilengitide in patients (pts) with castrate resistant prostate cancer (CRPC).

methodsChemotherapy-naïve, asymptomatic metastatic CRPC pts were randomized to cilengitide 500 mg or 2,000 mg IV twice weekly using parallel 2-stage design. The primary endpoint was rate of objective clinical progression at 6-months. Secondary endpoints included clinical and PSA response rates, safety and effects of cilengitide treatment on circulating tumor cells (CTCs) and bone remodeling markers.

resultsForty-four pts were accrued to first stage (22/arm). Median number of cycles was three in both arms (500 mg arm: 1-8; 2,000 mg arm: 1-15). At 6 months, two pts (9%) on the 500 mg arm and five pts (23%) on the 2,000 mg arm had not progressed. Best objective response was stable disease (SD) in seven pts for 9.9[8.1,20.9] months. There were three grade 3 and no grade 4 toxicities. At 12 weeks, analysis of bone markers did not reveal significant trends. At progression, bone specific alkaline phosphatase and N-telopeptide increased in all pts, less so in pts on the 2,000 mg arm and in pts on both arms who obtained SD at 6 months. CTCs increased over time in both arms.

conclusionCilengitide was well tolerated with modest clinical effect in favor of the higher dose. The unique trial design including a shift from response rate to objective progression as the endpoint, and not acting on PSA increases was feasible.

Indexed as

AgedAged, 80 and overAlkaline PhosphataseAntineoplastic AgentsCollagen Type IDisease ProgressionDose-Response Relationship, DrugFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisNeoplastic Cells, CirculatingPeptidesProstate-Specific AntigenProstatic NeoplasmsAlkaline PhosphataseAntineoplastic AgentsCilengitideCollagen Type Icollagen type I trimeric cross-linked peptidePeptidesProstate-Specific AntigenSnake Venoms

Identifiers

PMID20336348
PMCPMC2917503
OpenAlexW2083294486

What OpenQuestion holds

Textmetadata
LicenceTDM
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.