Evidence map›Paper›PMID 21276608›Full record

Trial reportGynecologic oncology2011

A phase II, single-arm study of the anti-α5β1 integrin antibody volociximab as monotherapy in patients with platinum-resistant advanced epithelial ovarian or primary peritoneal cancer.

Katherine M Bell-McGuinn, Carolyn M Matthews, Steffan N Ho, Minal Barve, Lucy Gilbert, Richard T Penson, Ernst Lengyel, Rameshraja Palaparthy, Kye Gilder, Artemios Vassos and 4 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 95 papers.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed
11.2field-weighted citation impact, top 1% 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

95 citing papers in PubMed, 167 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Role and mechanism of Integrin α5β1 in bone formation and disease.Frontiers in cell and developmental biology · 2025
    Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

35 more citing papers are in PubMed but not listed here.

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 8 institutions in 2 countries.

Katherine M Bell-McGuinnMemorial Sloan-Kettering Cancer Center, New York, NY 10065, USA. bell-mck@mskcc.org
Carolyn M Matthews
Steffan N Ho
Minal Barve
Lucy Gilbert
Richard T Penson
Ernst Lengyel
Rameshraja Palaparthy
Kye Gilder
Artemios Vassos
William McAuliffe
Sara Weymer
Jeremy Barton
Russell J Schilder
Biogen (United States) · USFox Chase Cancer Center · USMary Crowley Cancer Research Center · USMassachusetts General Hospital · USMcGill University · CAMemorial Sloan Kettering Cancer Center · USTexas Oncology · USUniversity of Chicago · US

Funding

Regulation of Adhesion and Proteolysis in Ovarian CancerR01CA111882 · NCI · UNIVERSITY OF CHICAGO · PI LENGYEL, ERNST · 2006 to 2016
$2.8M
Tumor Targeted Nanobins for the Treatment of Metastatic Breast and Ovarian CancerU01CA151461 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI O'HALLORAN, THOMAS V · 2010 to 2014
$2.2M
NCI NIH HHS R01 CA111882NCI NIH HHS U01 CA151461
6 · The paper itself

Abstract

objectiveThis phase II, multicenter, single-arm, two-stage study in platinum-resistant, advanced epithelial ovarian or primary peritoneal cancer evaluated the efficacy, safety, and tolerability of weekly single-agent volociximab. Pharmacokinetic/pharmacodynamic (PK/PD) studies were also performed.

methodsSixteen patients were enrolled in Stage 1. Volociximab was administered at 15mg/kg IV qwk until progression of disease or drug intolerability. Tumor response was assessed every 8weeks. Serum samples for PK or whole blood for the evaluation of circulating tumor cells, endothelial cells, and endothelial progenitor cells were obtained on Days 1, 8, 15, 29, and 50. Ascites from one patient was collected for volociximab concentration analysis. Archived tumor tissue was analyzed by immunohistochemistry (IHC) for α5 integrin expression.

resultsSafety data are available on all 16 patients; 14 were evaluable for efficacy. One patient had stable disease at 8weeks. The remaining 13 progressed on treatment. Twelve patients (75%) experienced study-related adverse events (AEs); the most common (≥20%) were headache and fatigue. Three patients experienced possible study-related serious AEs (SAEs): reversible posterior leukoencephalopathy syndrome, pulmonary embolism, and hyponatremia. Peak serum concentrations of volociximab increased 2-3 fold from Day 1 to Day 50. Clinically relevant trough levels were achieved (>150μg/mL). IHC analysis of archived tumor sections showed low-to-moderate expression of α5 integrin on all ovarian cancer tissue evaluated.

conclusionDespite insufficient clinical activity in this refractory patient population to continue the study, weekly volociximab was well tolerated, and the gained understanding of the mechanism of action of volociximab will inform future development efforts.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalBiomarkers, TumorCarcinoma, Ovarian EpithelialDrug Resistance, NeoplasmEndothelial CellsFemaleHumansImmunohistochemistryIntegrin alpha5beta1Middle AgedNeoplasms, Glandular and EpithelialNeoplastic Cells, CirculatingOrganoplatinum CompoundsOvarian NeoplasmsAntibodies, MonoclonalBiomarkers, TumorIntegrin alpha5beta1Organoplatinum Compoundsvolociximab

Identifiers

PMID21276608
PMCPMC4426879
OpenAlexW2000845191

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.