Evidence map›Paper›PMID 19711464›Full record

Trial reportCancer2009

Vorinostat in advanced prostate cancer patients progressing on prior chemotherapy (National Cancer Institute Trial 6862): trial results and interleukin-6 analysis: a study by the Department of Defense Prostate Cancer Clinical Trial Consortium and University of Chicago Phase 2 Consortium.

Deborah Bradley, Dana Rathkopf, Rodney Dunn, Walter M Stadler, Glenn Liu, David C Smith, Roberto Pili, James Zwiebel, Howard Scher, Maha Hussain

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed
–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

78 citing papers in PubMed.

  1. Trial
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  4. Off-target binding of the histone deacetylase inhibitor vorinostat to carbonic anhydrase II and IX.Acta crystallographica. Section F, Structural biology communications · 2025
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  5. Review
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  7. Identification of epigenetic monotherapy candidates in taxane-resistant CRPC.Turkish journal of biology = Turk biyoloji dergisi · 2025
    Article
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18 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

10 authors.

Deborah BradleyDepartment of Medicine and Urology, University of Michigan, Ann Arbor, Michigan, USA.
Dana Rathkopf
Rodney Dunn
Walter M Stadler
Glenn Liu
David C Smith
Roberto Pili
James Zwiebel
Howard Scher
Maha Hussain

Funding

MICHIGAN INSTITUTE FOR CLINICAL AND HEALTH RESEARCH (MICHR) (UL1): (BPCA)UL1RR024986 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$51.2M
ONCOLOGY RESEARCH TRAINING GRANTT32CA009357 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Qing Li · 1987 to 2026
$8.6M
NKLAM--A NOVEL GENE REQUIRED FOR NK FUNCTIONR01CA062201 · NCI · UNIVERSITY OF ARKANSAS MED SCIS LTL ROCK · PI KORNBLUTH, JACKI · 1994 to 1996
–
NCI NIH HHS N01 CM062201NCI NIH HHS N01-CM-62,201NCI NIH HHS PC051375NCI NIH HHS PC051382NCI NIH HHS T32 CA009357NCI NIH HHS T32CA009357NCRR NIH HHS UL1 RR024986NCRR NIH HHS UL1RR024986PHS HHS N008367
6 · The paper itself

Abstract

backgroundThis phase 2 trial was designed to evaluate the efficacy of vorinostat in chemotherapy-pretreated patients with metastatic castration-resistant prostate cancer.

methodsPatients with disease progression on 1 prior chemotherapy, a prostate-specific antigen (PSA) >or=5 ng/mL, and adequate organ function were treated with 400 mg vorinostat orally daily. The primary endpoint was the 6-month progression rate. Secondary endpoints included safety, rate of PSA decline, objective response, overall survival, and effects of vorinostat on serum interleukin-6 (IL-6) levels.

resultsTwenty-seven eligible patients were accrued. The median number of cycles delivered was 2 (range, 1-7). All patients were taken off therapy before 6 months. The best objective response in the eligible patient was stable disease in 2 (7%) patients. No PSA decline of >or=50% was observed. There was 1 grade 4 adverse event (AE), and 44% of patients experienced grade 3 adverse events. The most common adverse events were fatigue (81%), nausea (74%), anorexia (59%), vomiting (33%), diarrhea (33%), and weight loss (26%). Median time to progression and overall survival were 2.8 and 11.7 months, respectively. Median IL-6 levels (pg/mL) were higher in patients removed from the protocol for toxicity compared with progression at all time points, including baseline (5.2 vs 2.1, P = .02), Day 15 Cycle 1 (9.5 vs 2.2, P = .01), Day 1 Cycle 2 (9.8 vs 2.2, P = .01), and end of study (11.0 vs 2.9, P = .09).

conclusionsVorinostat at this dose was associated with significant toxicities limiting efficacy assessment in this patient population. The significant association between IL-6 levels and removal from the study for toxicities warrants further investigation.

Indexed as

AgedAged, 80 and overAndrogen AntagonistsAntineoplastic AgentsDrug Resistance, NeoplasmEnzyme InhibitorsHistone Deacetylase InhibitorsHumansHydroxamic AcidsInterleukin-6MaleMiddle AgedProstatic NeoplasmsSurvival AnalysisVorinostatAndrogen AntagonistsAntineoplastic AgentsEnzyme InhibitorsHistone Deacetylase InhibitorsHydroxamic AcidsInterleukin-6Vorinostat

Identifiers

PMID19711464
PMCPMC2917101

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.