Evidence map›Paper›PMID 26780387›Full record

Trial reportBJU international2016

Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients with metastatic castration-resistant prostate cancer.

Ravi A Madan, Fatima H Karzai, Yang-Min Ning, Bamidele A Adesunloye, Xuan Huang, Nancy Harold, Anna Couvillon, Guinevere Chun, Lisa Cordes, Tristan Sissung and 15 more

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

Trial report in BJU international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.3field-weighted citation impact, top 11% 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

16 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Targeting prostate adenocarcinoma tumor microenvironment via cancer nanotheranostics: a comprehensive update on improved roadmap for disease diagnosis, therapy and management.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. Computational drug discovery for castration-resistant prostate cancers through in vitro drug response modeling.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Article
  8. Article
  9. Metronomic Chemotherapy in Prostate Cancer.Journal of clinical medicine · 2022
    Review
  10. Article
  11. Review
  12. Targeting Angiogenesis in Prostate Cancer.International journal of molecular sciences · 2019
    Review
  13. Review
  14. Article
  15. Article
  16. 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

25 authors at 4 institutions in 2 countries.

Ravi A MadanGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Fatima H KarzaiGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Yang-Min NingGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Bamidele A AdesunloyeGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Xuan HuangGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Nancy HaroldGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Anna CouvillonGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Guinevere ChunGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Lisa CordesGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Tristan SissungGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Shaunna L BeedieGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Nancy A DawsonLombardi Comprehensive Cancer Center, Georgetown University, Washington, D.C., USA.
Marc R TheoretGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
David G McLeodCenter for Prostate Disease Research, Walter Reed National Military Medical Center, Bethesda, MD, USA.
Inger RosnerCenter for Prostate Disease Research, Walter Reed National Military Medical Center, Bethesda, MD, USA.
Jane B TrepelDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Min-Jung LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Yusuke TomitaDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Sunmin LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Clara ChenRadiology and Imaging Sciences, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Seth M SteinbergGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Philip M ArlenGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
James L GulleyGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
William D FiggGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA. wdfigg@helix.nih.gov.
William L DahutGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
National Cancer Institute · USCenter for Cancer Research · USWalter Reed National Military Medical Center · USGeorgetown University · US

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Sample Processing and Analytical Methods Development for New Anticancer AgentsZICSC006536 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$18.1M
Drug Development for Prostate Cancer and other Metastatic ProcessesZIABC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$10.2M
Clinical trials employing cancer vaccine combination therapiesZIABC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2022
$9.6M
Development of Anticancer AgentsZIASC006538 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$8.6M
Development of Drugs That Target Prostate CancerZ01BC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2003 to 2008
$463k
Intramural NIH HHS Z01 BC010547
6 · The paper itself

Abstract

objectiveTo determine the safety and clinical efficacy of two anti-angiogenic agents, bevacizumab and lenalidomide, with docetaxel and prednisone. PATIENTS AND

methodsEligible patients with metastatic castration-resistant prostate cancer enrolled in this open-label, phase II study of lenalidomide with bevacizumab (15 mg/kg), docetaxel (75 mg/m(2) ) and prednisone (10 mg daily). Docetaxel and bevacizumab were administered on day 1 of a 3-week treatment cycle. To establish safety, lenalidomide dosing in this combination was escalated in a conventional 3 + 3 design (15, 20 and 25 mg daily for 2 weeks followed by 1 week off). Patients received supportive measures including prophylactic pegfilgrastim and enoxaparin. The primary endpoints were safety and clinical efficacy.

resultsA total of 63 patients enrolled in this trial. Toxicities were manageable with most common adverse events (AEs) being haematological, and were ascertained by weekly blood counts. Twenty-nine patients (46%) had grade 4 neutropenia, 20 (32%) had grade 3 anaemia and seven (11%) had grade 3 thrombocytopenia. Despite frequent neutropenia, serious infections were rare. Other common non-haematological grade 3 AEs included fatigue (10%) and diarrhoea (10%). Grade 2 AEs in >10% of patients included anorexia, weight loss, constipation, osteonecrosis of the jaw, rash and dyspnoea. Of 61 evaluable patients, 57 (93%), 55 (90%) and 33 (54%) had PSA declines of >30, >50 and >90%, respectively. Of the 29 evaluable patients, 24 (86%) had a confirmed radiographic partial response. The median times to progression and overall survival were 18.2 and 24.6 months, respectively.

conclusionsWith appropriate supportive measures, combination angiogenesis inhibition can be safely administered and potentially provide clinical benefit. These hypothesis-generating data would require randomized trials to confirm the findings.

Indexed as

AgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Agents, HormonalBevacizumabHumansLenalidomideMaleMiddle AgedPrednisoneProstatic Neoplasms, Castration-ResistantThalidomideAngiogenesis InhibitorsAntineoplastic Agents, HormonalBevacizumabLenalidomidePrednisoneThalidomideangiogenesis inhibitioncombinationation therapydocetaxel coimbinationmetastatic castration resistant prostate cancerprostate cancer

Identifiers

PMID26780387
PMCPMC6387685
OpenAlexW2297146977

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.