Evidence map›Paper›PMID 19547919›Full record

Trial reportInvestigational new drugs2010

Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors.

Darren R Feldman, Stefan Turkula, Michelle S Ginsberg, Nicole Ishill, Sujata Patil, Maryann Carousso, George J Bosl, Robert J Motzer

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00453310 (A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 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.

NCT00453310 phase2completednot on this map

A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2007 to 2008Enrolled10ConditionsExtragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell TumorArmssunitinib malate
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Review
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  10. Clinical Challenges in the Management of Malignant Ovarian Germ Cell Tumours.International journal of environmental research and public health · 2023
    Review
  11. Article
  12. Loss of liver kinase B1 in human seminoma.Frontiers in oncology · 2023
    Article
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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

8 authors.

Darren R FeldmanGenitourinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, USA. feldmand@mskcc.org
Stefan Turkula
Michelle S Ginsberg
Nicole Ishill
Sujata Patil
Maryann Carousso
George J Bosl
Robert J Motzer

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vascular endothelial growth factor (VEGF) overexpression and increased angiogenesis have been proposed as having biologic importance in germ cell tumors (GCT). We conducted a single-institution phase II trial of sunitinib, an oral inhibitor of the VEGF receptor, in patients with relapsed or refractory GCT. A Simon's two-stage design was used to determine the number of patients for enrollment. Responses were assessed using a modified version of Response Evaluation Criteria in Solid Tumors (RECIST), taking into account tumor marker changes. Dose modifications were made according to a nomogram for adverse events. Ten patients were enrolled. The first five received sunitinib 50 mg for four consecutive weeks, followed by a two-week break (4/2). Since four of five treated on this schedule had some tumor marker decline during the four-week "on" period, with subsequent rise during the two-week break, the dose was changed to 37.5 mg continuously for patients six to ten. However, only marker stabilization (no declines) was seen. Overall, there were no objective responses: Five had stable disease and five progressive disease (PD). Sunitinib was well tolerated; only one patient required a dose reduction due to grade 3 mucositis. Two patients experienced tumor-related hemorrhage (grade 3 and grade 1). All patients developed PD within three cycles. Sunitinib is well tolerated, but at standard doses, does not demonstrate significant activity in highly refractory GCT. Correlation between sunitinib treatment and tumor marker changes on the 50 mg 4/2 schedule suggest some pathways targeted by sunitinib (ie, angiogenesis) may be important to GCT biology.

Indexed as

AdultAntineoplastic AgentsBiomarkers, TumorDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmHumansIndolesMaleMediastinal NeoplasmsMiddle AgedNeoplasms, Germ Cell and EmbryonalPyrrolesSecondary PreventionSunitinibTesticular NeoplasmsAntineoplastic AgentsBiomarkers, TumorIndolesPyrrolesSunitinib

Identifiers

PMID19547919

What OpenQuestion holds

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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.