Evidence map›Paper›PMID 27998970›Full record

ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2017

A phase I trial of paclitaxel, cisplatin, and veliparib in the treatment of persistent or recurrent carcinoma of the cervix: an NRG Oncology Study (NCT#01281852).

P H Thaker, R Salani, W E Brady, H A Lankes, D E Cohn, D G Mutch, R S Mannel, K M Bell-McGuinn, P A Di Silvestro, D Jelovac and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01281852 (A Limited Access Phase I Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
5.0field-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.

NCT01281852 phase1completednot on this map

A Limited Access Phase I Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888 (Veliparib) (NSC#737664) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2011 to 2017Enrolled37ConditionsCervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical CarcinomaArmsCisplatin, Laboratory Biomarker Analysis, Paclitaxel, Veliparib
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 80 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Viral oncogenesis in cancer: from mechanisms to therapeutics.Signal transduction and targeted therapy · 2025
    Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. PARP inhibitors in non-ovarian gynecologic cancers.Therapeutic advances in medical oncology · 2024
    Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Soursop leaves (Saudi journal of biological sciences · 2022
    Article
  20. New Advances in Cervical Cancer: From Bench to Bedside.International journal of environmental research and public health · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 1 country.

P H ThakerDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Siteman Cancer Center, Washington University School of Medicine, St. Louis.
R SalaniDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University School of Medicine, Columbus, USA.
W E BradyNRG/Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, USA.
H A LankesNRG/Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, USA.
D E CohnDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University School of Medicine, Columbus, USA.
D G MutchDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Siteman Cancer Center, Washington University School of Medicine, St. Louis.
R S MannelDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma, Oklahoma City, USA.
K M Bell-McGuinnDepartment of Medicine, Gynecologic Medical Oncology Service, Memorial Sloan Kettering Cancer Center, New York, USA.
P A Di SilvestroDepartment of Obstetrics and Gynecology, Women & Infants Hospital, Providence, USA.
D JelovacDivision of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, USA.
J S CarterDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, USA.
W DuanDivision of Medical Oncology, Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, USA.
K E ResnickDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Case Western Reserve University School of Medicine, Cleveland, USA.
D S DizonDivision of Medical Gynecologic Oncology, Massachusetts General Hospital Cancer Center, Boston, USA.
C AghajanianDepartment of Medicine, Gynecologic Medical Oncology Service, Memorial Sloan Kettering Cancer Center, New York, USA.
P M FracassoDivision of Hematology/Oncology, Department of Medicine, University of Virginia, Charlottesville, USA.
The Ohio State University · USMemorial Sloan Kettering Cancer Center · USWashington University in St. Louis · USCase Western Reserve University · USGynecologic Oncology Group · USMassachusetts General Hospital · USProvidence College · USRoswell Park Comprehensive Cancer Center · USSidney Kimmel Comprehensive Cancer Center · USUniversity of Oklahoma · USUniversity of Virginia · USVirginia Commonwealth University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA196067
6 · The paper itself

Abstract

Background: Preclinical studies demonstrate poly(ADP-ribose) polymerase (PARP) inhibition augments apoptotic response and sensitizes cervical cancer cells to the effects of cisplatin. Given the use of cisplatin and paclitaxel as first-line treatment for persistent or recurrent cervical cancer, we aimed to estimate the maximum tolerated dose (MTD) of the PARP inhibitor veliparib when added to chemotherapy. Patients and methods: Women with persistent or recurrent cervical carcinoma not amenable to curative therapy were enrolled. Patients had to have received concurrent chemotherapy and radiation as well as possible consolidation chemotherapy; have adequate organ function. The trial utilized a standard 3 + 3 phase I dose escalation with patients receiving paclitaxel 175 mg/m2 on day 1, cisplatin 50 mg/m2 on day 2, and escalating doses of veliparib ranging from 50 to 400 mg orally two times daily on days 1-7. Cycles occurred every 21 days until progression. Dose-limiting toxicities (DLTs) were assessed at first cycle. Fanconi anemia complementation group D2 (FANCD2) foci was evaluated in tissue specimens as a biomarker of response. Results: Thirty-four patients received treatment. DLTs (n = 1) were a grade 4 dyspnea, a grade 3 neutropenia lasting ≥3 weeks, and febrile neutropenia. At 400 mg dose level (DL), one of the six patients had a DLT, so the MTD was not reached. Across DLs, the objective response rate (RR) for 29 patients with measurable disease was 34% [95% confidence interval (CI), 20%-53%]; at 400 mg DL, the RR was 60% (n = 3/5; 95% CI, 23%-88%). Median progression-free survival was 6.2 months (95% CI, 2.9-10.1), and overall survival was 14.5 months (95% CI, 8.2-19.4). FANCD2 foci was negative or heterogeneous in 31% of patients and present in 69%. Objective RR were not associated with FANCD2 foci (P = 0.53). Conclusions: Combining veliparib with paclitaxel and cisplatin as first-line treatment for persistent or recurrent cervical cancer patients is safe and feasible. Clinical trial information: NCT01281852.

Indexed as

AdultAgedBenzimidazolesCarcinomaCisplatinDisease-Free SurvivalFemaleHumansMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalPaclitaxelPoly (ADP-Ribose) Polymerase-1Poly(ADP-ribose) PolymerasesUterine Cervical NeoplasmsBenzimidazolesCisplatinPaclitaxelPARP1 protein, humanPARP2 protein, humanPoly (ADP-Ribose) Polymerase-1Poly(ADP-ribose) Polymerasesveliparibcervical cancernovel therapeuticsPARP inhibitors

Identifiers

PMID27998970
PMCPMC5815561
OpenAlexW2562779990

What OpenQuestion holds

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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.