Evidence map›Paper›PMID 17156477›Full record

Trial reportBMC cancer2006

A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer.

Helmut Friess, Jan M Langrehr, Helmut Oettle, Jochen Raedle, Marco Niedergethmann, Christian Dittrich, Dieter K Hossfeld, Herbert Stöger, Bart Neyns, Peter Herzog and 15 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 7 pooled it
4.6field-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

60 citing papers in PubMed, 7 syntheses or guidelines pooled it, 122 citations in OpenAlex.

  1. Pooled it
  2. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
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  4. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
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  8. Review
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  13. TGF-β signaling in health, disease, and therapeutics.Signal transduction and targeted therapy · 2024
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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

25 authors at 20 institutions in 7 countries.

Helmut FriessDepartment of General Surgery, University of Heidelberg, Heidelberg, Germany. helmut_friess@med.uni-heidelberg.de
Jan M Langrehr
Helmut Oettle
Jochen Raedle
Marco Niedergethmann
Christian Dittrich
Dieter K Hossfeld
Herbert Stöger
Bart Neyns
Peter Herzog
Pascal Piedbois
Frank Dobrowolski
Werner Scheithauer
Robert Hawkins
Frieder Katz
Peter Balcke
Jan Vermorken
Simon van Belle
Neville Davidson
Albert Abad Esteve
Daniel Castellano
Jörg Kleeff
Adrien A Tempia-Caliera
Andreas Kovar
Johannes Nippgen
Heidelberg University · DECharité - Universitätsmedizin Berlin · DEMerck (Germany) · DEAlbyn Hospital · GBAntwerp University Hospital · BEGhent University Hospital · BEHôpitaux Universitaires Henri-Mondor · FRHospital Universitari Germans Trias i Pujol · ESHospital Universitario 12 De Octubre · ESKlinikum Darmstadt · DEKlinikum Wilhelmshaven · DELudwig Boltzmann Institute for Cancer Research · ATMedical University of Graz · ATSt. Pölten University of Applied Sciences · ATUniversität Hamburg · DEUniversity Hospital Carl Gustav Carus · DEUniversity Hospital Frankfurt · DEUniversity Hospital Heidelberg · DEUniversity of Manchester · GBVienna General Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer. In this study, the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer.

methodsA multi-national, open-label, controlled, randomized, parallel-group, phase II pilot study was conducted in 20 centers in 7 countries. Cilengitide was administered at 600 mg/m2 twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m2 for 3 weeks followed by a week of rest per cycle. The planned treatment period was 6 four-week cycles. The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival (PFS), response rate, quality of life (QoL), effects on biological markers of disease (CA 19.9) and angiogenesis (vascular endothelial growth factor and basic fibroblast growth factor), and safety. An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients.

resultsEighty-nine patients were randomized. The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone. The median PFS times were 3.6 months and 3.8 months, respectively. The overall response rates were 17% and 14%, and the tumor growth control rates were 54% and 56%, respectively. Changes in the levels of CA 19.9 went in line with the clinical course of the disease, but no apparent relationships were seen with the biological markers of angiogenesis. QoL and safety evaluations were comparable between treatment groups. Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa.

conclusionThere were no clinically important differences observed regarding efficacy, safety and QoL between the groups. The observations lay in the range of other clinical studies in this setting. The combination regimen was well tolerated with no adverse effects on the safety, tolerability and pharmacokinetics of either agent.

Indexed as

AdultAngiogenesis InhibitorsAntimetabolites, AntineoplasticCell DivisionDeoxycytidineGemcitabineHumansPancreatic NeoplasmsQuality of LifeSnake VenomsSurveys and QuestionnairesSurvival RateAngiogenesis InhibitorsAntimetabolites, AntineoplasticCilengitideDeoxycytidineGemcitabineSnake Venoms

Identifiers

PMID17156477
PMCPMC1764757
OpenAlexW2115068140

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.