Evidence map›Paper›PMID 21049281›Full record

Trial reportInvestigational new drugs2012

Phase II study of cilengitide (EMD 121974, NSC 707544) in patients with non-metastatic castration resistant prostate cancer, NCI-6735. A study by the DOD/PCF prostate cancer clinical trials consortium.

Ajjai Alva, Susan Slovin, Stephanie Daignault, Michael Carducci, Robert Dipaola, Ken Pienta, David Agus, Kathleen Cooney, Alice Chen, David C Smith and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00121238 (Phase II Evaluation of EMD 121974), which is not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
4.1field-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.

NCT00121238 phase2completednot on this map

Phase II Evaluation of EMD 121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen Independent Prostate Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2005 to 2015Enrolled16ConditionsRecurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate CancerArmscilengitide
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 86 citations in OpenAlex.

  1. Trial
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  4. Review
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  8. TGF-β signaling in health, disease, and therapeutics.Signal transduction and targeted therapy · 2024
    Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Targeting Integrins for Cancer Therapy - Disappointments and Opportunities.Frontiers in cell and developmental biology · 2022
    Review
  14. Integrin αJournal of nanobiotechnology · 2021
    Article
  15. Article
  16. Review
  17. Targeting TGFβ signal transduction for cancer therapy.Signal transduction and targeted therapy · 2021
    Review
  18. The roles of integrins in cancer.Faculty reviews · 2021
    Review
  19. Cell Adhesion Molecules in Plasticity and Metastasis.Molecular cancer research : MCR · 2021
    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

11 authors at 7 institutions in 1 country.

Ajjai AlvaUniversity of Michigan Comprehensive Cancer Center, 7314 Cancer Center, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5946, USA.
Susan Slovin
Stephanie Daignault
Michael Carducci
Robert Dipaola
Ken Pienta
David Agus
Kathleen Cooney
Alice Chen
David C Smith
Maha Hussain
University of Michigan–Ann Arbor · USCancer Institute of Florida · USJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USMichigan Center for Translational Pathology · USNational Cancer Institute · USUniversity of Southern California · US

Funding

NCI NIH HHS N01 CM062206NCI NIH HHS PC051375NCI NIH HHS PC051382
6 · The paper itself

Abstract

backgroundIntegrins mediate invasion and angiogenesis in prostate cancer bone metastases. We conducted a phase II study of cilengitide, a selective antagonist of α(v)β(3) and α(v)β(5) integrins, in non-metastatic castration resistant prostate cancer with rising PSA.

methodsPatients were observed for 4 weeks with PSA monitoring, and then treated with 2,000 mg IV of cilengitide twice weekly until toxicity/progression. PSA, circulating tumor cells (CTCs) and circulating endothelial cells (CECs) were monitored each cycle with imaging performed every three cycles. Primary end point was PSA decline by ≥ 50%. Secondary endpoints were safety, PSA slope, time to progression (TTP), overall survival (OS), CTCs, CECs and gene expression.

results16 pts were enrolled; 13 were eligible with median age 65.5 years, baseline PSA 8.4 ng/mL and median Gleason sum 7. Median of three cycles was administered. Treatment was well tolerated with two grade three toxicities and no grade four toxicities. There were no PSA responses; 11 patients progressed by PSA after three cycles. Median TTP was 1.8 months and median OS has not been reached. Median pre- and on-treatment PSA slopes were 1.1 and 1.8 ng/mL/month. Baseline CTCs were detected in 1/9 patients. CTC increased (0 to 1; 2 pts), remained at 0 (2 pts) or decreased (23 to 0; 1 patient) at progression. Baseline median CEC was 26 (0-61) and at progression, 47 (15-148). Low cell counts precluded gene expression studies.

conclusionsCilengitide was well tolerated but had no detectable clinical activity. CTCs are of questionable utility in non-metastatic prostate cancer.

Indexed as

Drug Resistance, NeoplasmAgedAndrogen AntagonistsAntineoplastic AgentsDisease ProgressionDrug Administration ScheduleEndothelial CellsHumansInfusions, IntravenousIntegrin alphaVbeta3Kaplan-Meier EstimateMaleMiddle AgedNeoplasm GradingNeoplastic Cells, CirculatingProstate-Specific AntigenAndrogen AntagonistsAntineoplastic AgentsCilengitideIntegrin alphaVbeta3integrin alphaVbeta5Prostate-Specific AntigenReceptors, VitronectinSnake Venoms

Identifiers

PMID21049281
PMCPMC3175265
OpenAlexW2034000571

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.