Evidence map›Paper›PMID 25016924›Full record

Trial reportGynecologic oncology2014

A phase II study of ramucirumab (IMC-1121B) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.

Richard T Penson, Kathleen M Moore, Gini F Fleming, Patricia Braly, Veronica Schimp, Hoa Nguyen, Ursula A Matulonis, Susana Banerjee, Paul Haluska, Martin Gore and 6 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. The expansion of targetable biomarkers for CAR T cell therapy.Journal of experimental & clinical cancer research : CR · 2018
    Review
  11. Article
  12. Article
  13. Ramucirumab (Cyramza): A Breakthrough Treatment for Gastric Cancer.P & T : a peer-reviewed journal for formulary management · 2015
    Article
  14. Article
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

16 authors.

Richard T PensonMassachusetts General Hospital for the Dana-Farber/Harvard Cancer Center, Boston, MA, USA.
Kathleen M MooreUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Gini F FlemingUniversity of Chicago Medical Center, Chicago, IL, USA.
Patricia BralyHematology and Oncology Specialists, LLC, Marrero, LA, USA.
Veronica SchimpMD Anderson Cancer Center, Orlando, FL, USA.
Hoa NguyenGynecologic Oncology Associates, Inc., Hollywood, USA.
Ursula A MatulonisDana-Farber Cancer Institute, Boston, MA, USA.
Susana BanerjeeRoyal Marsden Hospital, Surrey, England, UK.
Paul HaluskaMayo Clinic, Rochester, MN, USA.
Martin GoreRoyal Marsden Hospital, London, England, UK.
Diane C BodurkaUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rebecca R HozakEli Lilly and Company, Indianapolis, IN, USA.
Adarsh JoshiEli Lilly and Company, Indianapolis, IN, USA.
Yihuan XuImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ, USA.
Jonathan D SchwartzImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ, USA.
William P McGuireInova Fairfax Hospital, Falls Church, VA, USA.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

objectiveVascular endothelial growth factor (VEGF) receptor-mediated signaling contributes to ovarian cancer pathogenesis. Elevated VEGF expression is associated with poor clinical outcomes. We investigated ramucirumab, a fully human anti-VEGFR-2 antibody, in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Primary endpoints were progression-free survival at 6 months (PFS-6) and confirmed objective response rate (ORR).

methodsWomen who received ≥ 1 platinum-based chemotherapeutic regimen and had a platinum-free interval of <12 months with measurable disease were eligible. Patients received 8 mg/kg ramucirumab intravenously every 2 weeks.

resultsSixty patients were treated; one patient remained on study as of September 2013. The median age was 62 years (range: 27-80), and median number of prior regimens was 3. Forty-five (75%) patients had platinum refractory/resistant disease. Thirty-nine patients (65.0%) had serous tumors. PFS-6 was 25.0% (n=15/60, 95% CI: 14.7-37.9%). Best overall response was: partial response 5.0% (n=3/60), stable disease 56.7% (n=34/60), and progressive disease 33.3% (n=20/60). The most common treatment-emergent adverse events possibly related to study drug were headache (65.0%; 10.0% Grade ≥ 3), fatigue (56.7%; 3.3% Grade ≥ 3), diarrhea (28.3%; 1.7% Grade ≥ 3), hypertension (25.0%; 3.3% Grade ≥ 3), and nausea (20.0%; no Grade ≥ 3). Two patients experienced intestinal perforations (3.3% Grade ≥ 3). Pharmacodynamic analyses revealed changes in several circulating VEGF proteins following initial ramucirumab infusion, including increased VEGF-A, PlGF and decreased sVEGFR-2.

conclusionsAlthough antitumor activity was observed, the predetermined efficacy endpoints were not met.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinomaDisease-Free SurvivalFallopian Tube NeoplasmsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPeritoneal NeoplasmsRamucirumabSurvival RateAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedRamucirumabAngiogenesisAntiangiogenicClear cellResistantVEGF

Identifiers

PMID25016924
PMCPMC5166425

What OpenQuestion holds

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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.