Evidence map›Paper›PMID 20499131›Full record

Trial reportInvestigational new drugs2011

A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal® dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC).

Michael R Harrison, Noah M Hahn, Roberto Pili, William K Oh, Hans Hammers, Christopher Sweeney, Kyungmann Kim, Scott Perlman, Jamie Arnott, Carolyn Sidor and 2 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Investigational new drugs, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
5.1field-weighted citation impact, top 5% 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

56 citing papers in PubMed, 109 citations in OpenAlex.

  1. Article
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  6. Therapeutic Targeting of Hypoxia-Inducible Factors in Cancer.International journal of molecular sciences · 2024
    Review
  7. The Interplay Between HIF-1α and EZH2 in Lung Cancer and Dual-Targeted Drug Therapy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024
    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

12 authors at 8 institutions in 2 countries.

Michael R HarrisonUniversity of Wisconsin Carbone Cancer Center, Madison, WI 53705, USA. mrharris@medicine.wisc.edu
Noah M Hahn
Roberto Pili
William K Oh
Hans Hammers
Christopher Sweeney
Kyungmann Kim
Scott Perlman
Jamie Arnott
Carolyn Sidor
George Wilding
Glenn Liu
CASI Pharmaceuticals (United States) · USProstate Cancer UK · GBUniversity of Wisconsin Carbone Cancer Center · USUniversity of Wisconsin–Madison · USIndiana University – Purdue University Indianapolis · USJohns Hopkins Medicine · USMount Sinai Medical Center · USRoswell Park Comprehensive Cancer Center · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
Clinical Academic Oncologist Training ProgramK12CA087718 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ALBERTINI, MARK R · 2000 to 2008
$3.8M
NCI NIH HHS K12 CA087718NCI NIH HHS P30 CA014520NCI NIH HHS P30 CA14520
6 · The paper itself

Abstract

purpose2ME2 (Panzem®) is a non-estrogenic derivative of estradiol with antiproliferative and antiangiogenic activity. Preclinical data support antitumor activity in prostate cancer. This trial evaluated the efficacy of 2ME2 NCD in patients with taxane-refractory, metastatic CRPC. EXPERIMENTAL

designPatients with metastatic CRPC who had progressed on only one prior taxane-based regimen were eligible. All patients received 2ME2 NCD at 1,500 mg orally four times daily, repeated in 28 day cycles. The primary endpoint was progression-free survival at month 6, with a secondary endpoint of PSA response. An exploratory endpoint was metabolic response on FDG-PET imaging.

resultsA total of 50 pts was planned. The study was terminated after 21 pts when a futility analysis showed the primary endpoint was unlikely to be reached. The median number of cycles on study was 2 (range <1 to 12). Adverse events (AE) of grade ≥3 related to the study drug occurred in 7 unique patients (33%): elevations in liver function tests, fatigue or weakness, gastrointestinal hemorrhage, and hyponatremia. Paired FDG-PET scans were obtained for 11 pts. No metabolic responses were observed.

conclusions2ME2 NCD did not appear to have clinically significant activity in this study. 2ME2 NCD was well-tolerated and showed some evidence of biologic activity. Given the aggressive biology in this taxane-refractory population, the potential benefit from a cytostatic agent like 2ME2 might better be realized in the pre-chemotherapy (or rising PSA only) stage of CRPC.

Indexed as

Nanoparticles2-MethoxyestradiolAdministration, OralAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalEstradiolFluorodeoxyglucose F18HumansMaleMiddle AgedNeoplasm MetastasisPositron-Emission TomographyProstatic NeoplasmsRadiopharmaceuticals2-MethoxyestradiolAntineoplastic AgentsEstradiolFluorodeoxyglucose F18Radiopharmaceuticals

Identifiers

PMID20499131
PMCPMC3042040
OpenAlexW2079605491

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.