Evidence map›Paper›PMID 22664059›Full record

Trial reportGynecologic oncology2012

A phase 2 trial of flavopiridol (Alvocidib) and cisplatin in platin-resistant ovarian and primary peritoneal carcinoma: MC0261.

Keith C Bible, Prema P Peethambaram, Ann L Oberg, William Maples, David L Groteluschen, Matthew Boente, Jill K Burton, Leigh C Gomez Dahl, Jennifer D Tibodeau, Crescent R Isham and 11 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
7.2field-weighted citation impact, top 3% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Programmed cell death, redox imbalance, and cancer therapeutics.Apoptosis : an international journal on programmed cell death · 2021
    Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Pathogenesis and heterogeneity of ovarian cancer.Current opinion in obstetrics & gynecology · 2017
    Review
  15. Article
  16. Review
  17. Overview of CDK9 as a target in cancer research.Cell cycle (Georgetown, Tex.) · 2016
    Review
  18. 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

21 authors at 7 institutions in 1 country.

Keith C BibleDivision of Medical Oncology, Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA. bible.keith@mayo.edu
Prema P Peethambaram
Ann L Oberg
William Maples
David L Groteluschen
Matthew Boente
Jill K Burton
Leigh C Gomez Dahl
Jennifer D Tibodeau
Crescent R Isham
Jacie L Maguire
Viji Shridhar
Andrea K Kukla
Kalli J Voll
Mathew J Mauer
Alexander D Colevas
John Wright
L Austin Doyle
Charles Erlichman
Mayo Phase 2 Consortium (P2C)
North Central Cancer Treatment Group (NCCTG)
Mayo Clinic in Arizona · USMayo Clinic in Florida · USNational Cancer Institute · USMayo Clinic · USMetro-Minnesota Community Oncology Research Consortium · USUniversity of Wisconsin–Green Bay · USWinnMed · US

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Use of microfluidic tumor cultures to enable clinical trials of therapies for ovarian cancerP50CA136393 · NCI · MAYO CLINIC ROCHESTER · PI Zhenkun Lou · 2009 to 2026
$37.0M
Flavopiridol Targets Transcription Factor/DNA ComplexesR01CA097129 · NCI · MAYO CLINIC ROCHESTER · PI BIBLE, KEITH C. · 2003 to 2006
$1.2M
NCI NIH HHS CA097129NCI NIH HHS CM17104NCI NIH HHS CM62205NCI NIH HHS N01 CM062205NCI NIH HHS P30 CA015083NCI NIH HHS P50 CA136393NCI NIH HHS R01 CA097129
6 · The paper itself

Abstract

purposeBased upon promising preclinical and phase 1 trial results, combined flavopiridol and cisplatin therapy was evaluated in patients with ovarian and primary peritoneal cancers.

methodsA two cohort phase 2 trial of cisplatin (60 mg/m2 IV) immediately followed by flavopiridol (100 mg/m2 IV, 24 h infusion; 21 day cycles) was undertaken in patients with recurrent platin-sensitive or platin-resistant disease (progression>vs. ≤6 months following prior platin-based therapy). Measurable disease (RECIST)--or evaluable disease plus CA125>2X post-treatment nadir--and ECOG performance≤2 were required.

resultsForty-five patients were enrolled between December 23, 2004 and February 25, 2010: 40 platin-resistant (Group 1), and 5 platin-sensitive (Group 2). In Group 1, the median number of treatment cycles was 3 (range 2-12). Only 10% of patients incurred grade 4 toxicities, but grade 3 toxicities were common (65%): neutropenia (17.5%); nausea (12.5%); vomiting, fatigue, thrombosis, anemia (10% each). Seven patients (17.5%) achieved a confirmed response (1 CR, 6 PR; median duration 118 days); ten additional patients (25%) attained maintained stable disease. Median time to progression was 4.3 months; overall survival was 16.1 months. Pilot translational studies assessed ascites flavopiridol level; surrogate marker studies were uninformative. In Group 2, although 4 of 5 patients responded (2 confirmed PRs with median time to progression, 10.8 months and median overall survival 20.6 months) the cohort was closed due to poor accrual.

conclusionsThe assessed flavopiridol and cisplatin regimen displayed clinical activity in platin resistant and sensitive ovarian/primary peritoneal cancers, meriting further study.

Indexed as

AdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCell SurvivalCisplatinCohort StudiesDisease-Free SurvivalDrug Resistance, NeoplasmFemaleFlavonoidsHumansMiddle AgedOvarian NeoplasmsPeritoneal NeoplasmsPiperidinesalvocidibCisplatinFlavonoidsPiperidines

Identifiers

PMID22664059
PMCPMC4127485
OpenAlexW2068370462

What OpenQuestion holds

Textmetadata
LicenceTDM
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.