Evidence map›Paper›PMID 18423560›Full record

Trial reportGynecologic oncology2008

Efficacy and safety of bevacizumab plus erlotinib for patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer: a trial of the Chicago, PMH, and California Phase II Consortia.

Halla S Nimeiri, Amit M Oza, Robert J Morgan, Gregory Friberg, Kristen Kasza, Leonardo Faoro, Ravi Salgia, Walter M Stadler, Everett E Vokes, Gini F Fleming and 3 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing 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

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

  1. Pooled it
  2. Pooled it
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  4. Review
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  6. Article
  7. Review
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  9. Article
  10. The rise of genomic profiling in ovarian cancer.Expert review of molecular diagnostics · 2016
    Review
  11. Article
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  13. Review
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  15. Article
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  18. Network analysis identifies an HSP90-central hub susceptible in ovarian cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013
    Article
  19. Article
  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

13 authors.

Halla S NimeiriUniversity of Chicago, Chicago, IL 60637, USA.
Amit M Oza
Robert J Morgan
Gregory Friberg
Kristen Kasza
Leonardo Faoro
Ravi Salgia
Walter M Stadler
Everett E Vokes
Gini F Fleming
Chicago Phase II Consortium
PMH Phase II Consortium
California Phase II Consortium

Funding

Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Christine Hui · 1994 to 2026
$57.9M
NKLAM--A NOVEL GENE REQUIRED FOR NK FUNCTIONR01CA062201 · NCI · UNIVERSITY OF ARKANSAS MED SCIS LTL ROCK · PI KORNBLUTH, JACKI · 1994 to 1996
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REGULATION OF RADIATION-INDUCED APOPTOTIC CELL DEATHR29CA062209 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI STORY, MICHAEL D · 1994 to 1998
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NCI NIH HHS N01 CM062201NCI NIH HHS N01 CM062203NCI NIH HHS N01 CM062209NCI NIH HHS N01-CM-17107NCI NIH HHS N01-CM-62201NCI NIH HHS N01-CM-62203NCI NIH HHS N01-CM-62209
6 · The paper itself

Abstract

objectivesThe objectives of this phase II trial were to assess the activity and tolerability of the combination of bevacizumab and erlotinib in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.

methodsThis was a single arm, multicenter phase II trial with overall objective response as the primary endpoint. Eligible patients had two or fewer prior chemotherapy regimens for recurrent or refractory disease and no prior anti-VEGF or anti-EGFR agents. Bevacizumab, 15 mg/kg, was administered intravenously every 21 days and erlotinib, 150 mg orally, was given daily.

resultsBetween July and October 2005, 13 patients were enrolled. There were two major objective responses, one complete response of 16+ month duration and one partial response of 11 month duration, for a response rate of 15% (95% CI 1.9% to 45.4%). Seven patients had a best response of stable disease. The most common grade 3 or 4 toxicities included anemia (n=1), nausea (n=2), vomiting (n=1), hypertension (n=1), and diarrhea (n=2). One patient with an ileostomy was removed from the study secondary to grade 3 diarrhea. Two patients had fatal gastrointestinal perforations.

conclusionThere was no strong suggestion that this combination was superior to single agent bevacizumab, and the rate of gastrointestinal perforation was of concern. The study was therefore stopped. Identification of risk factors for gastrointestinal perforation will be of importance for the use of bevacizumab in the treatment of ovarian cancer.

Indexed as

AgedAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkersErlotinib HydrochlorideFallopian Tube NeoplasmsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPatient SelectionPeritoneal NeoplasmsAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabBiomarkersErlotinib HydrochlorideQuinazolinesVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-2

Identifiers

PMID18423560
PMCPMC2699608

What OpenQuestion holds

Textmetadata
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.