Evidence map›Paper›PMID 19451750›Full record

Trial reportPancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]2009

A phase II study of flavopiridol (Alvocidib) in combination with docetaxel in refractory, metastatic pancreatic cancer.

Richard D Carvajal, Archie Tse, Manish A Shah, Robert A Lefkowitz, Mithat Gonen, Lisa Gilman-Rosen, Jeremy Kortmansky, David P Kelsen, Gary K Schwartz, Eileen M O'Reilly

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

Trial report in Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.], 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

20 citing papers in PubMed, 44 citations in OpenAlex.

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  19. The CDK inhibitors in cancer research and therapy.Journal of cancer research and clinical oncology · 2011
    Review
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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

10 authors at 1 institution in 1 country.

Richard D CarvajalDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. carvajar@mskcc.org
Archie Tse
Manish A Shah
Robert A Lefkowitz
Mithat Gonen
Lisa Gilman-Rosen
Jeremy Kortmansky
David P Kelsen
Gary K Schwartz
Eileen M O'Reilly
Memorial Sloan Kettering Cancer Center · US

Funding

Investigational Cancer Therapeutics Training Program (ICTTP)T32CA009207 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Omar Abdel-Wahab, Alexander Drilon · 1985 to 2026
$13.7M
Summer research experiences for medical students supervised by faculty mentorsR25CA020449 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Charlotte Eielson Ariyan · 1985 to 2026
$6.2M
PROTEIN KINASE C--A NOVEL TARGET FOR CANCER THERAPYR01CA067819 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SCHWARTZ, GARY K · 1996 to 2008
$4.7M
NCI NIH HHS R01 CA067819NCI NIH HHS R25 CA020449NCI NIH HHS T32 CA009207
6 · The paper itself

Abstract

BACKGROUND/

aimsPancreatic adenocarcinoma (PC) harbors frequent alterations in p16, resulting in cell cycle dysregulation. A phase I study of docetaxel and flavopiridol, a pan-cyclin-dependent kinase inhibitor, demonstrated encouraging clinical activity in PC. This phase II study was designed to further define the efficacy and toxicity of this regimen in patients with previously treated PC.

methodsPatients with gemcitabine-refractory, metastatic PC were treated with docetaxel 35 mg/m(2) followed by flavopiridol 80 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. Tumor measurements were performed every two cycles. A Simon two-stage design was used to evaluate the primary endpoint of response.

resultsTen patients were enrolled, and 9 were evaluable for response. No objective responses were observed; however, 3 patients (33%) achieved transient stable disease, with one of these patients achieving a 20% reduction in tumor size. Median survival was 4.2 months, with no patients alive at the time of analysis. Adverse events were significant, with 7 patients (78%) requiring >or=1 dose reduction for transaminitis (11%), grade 4 neutropenia (33%), grade 3 fatigue (44%), and grade 3 diarrhea (22%).

conclusionsThe combination of flavopiridol and docetaxel has minimal activity and significant toxicity in this patient population. These results reflect the challenges of treating patients with PC in a second-line setting where the risk/benefit equation is tightly balanced.

Indexed as

AdenocarcinomaAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDocetaxelFemaleFlavonoidsHumansMaleMiddle AgedPancreatic NeoplasmsPiperidinesTaxoidsTreatment OutcomealvocidibDocetaxelFlavonoidsPiperidinesTaxoids

Identifiers

PMID19451750
PMCPMC4053191
OpenAlexW1973662639

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.