Evidence map›Paper›PMID 20387090›Full record

ArticleInvestigational new drugs2011

A phase I evaluation of the combination of vinflunine and erlotinib in patients with refractory solid tumors.

Hanna K Sanoff, Janine M Davies, Christine Walko, William Irvin, Larry Buie, Kimberly Keller, Anastasia Ivanova, Wing-Keung Chiu, Bert H O'Neil, Thomas E Stinchcombe and 1 more

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

Article 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 40% 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

2 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. 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

11 authors at 3 institutions in 1 country.

Hanna K SanoffDepartment of Medicine, Division of Hematology-Oncology, School of Medicine, University of North Carolina at Chapel Hill, 170 Manning Drive, 3rd Floor POB, CB 7305, Chapel Hill, NC 27599-7305, USA.
Janine M Davies
Christine Walko
William Irvin
Larry Buie
Kimberly Keller
Anastasia Ivanova
Wing-Keung Chiu
Bert H O'Neil
Thomas E Stinchcombe
E Claire Dees
UNC Lineberger Comprehensive Cancer CenterUniversity of North Carolina at Chapel Hill · USUniversity of North Carolina Hospitals · US

Funding

Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MUENZER, JOSEPH J. · 1985 to 2008
$38.5M
UNC Clinical Translation Science Award-K12 Scholars Program (KL2)KL2RR025746 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2008 to 2011
$9.0M
NCRR NIH HHS K12 RR025746NCRR NIH HHS KL2 RR025746NCRR NIH HHS M01 RR000046NCRR NIH HHS RR00046
6 · The paper itself

Abstract

purposeEpidermal growth factor receptor (EGFR) inhibition may overcome chemotherapy resistance by inhibiting important anti-apoptotic signals that are constitutively activated by an overstimulated EGFR pathway.

methodsThis phase I dose escalation trial assessed the safety and efficacy of vinflunine, a novel vinca alkaloid microtubule inhibitor, with erlotinib, an EGFR tyrosine kinase inhibitor, in patients with refractory solid tumors.

resultsSeventeen patients were treated, 10 with continuous erlotinib, and 7 with intermittent erlotinib. At dose level 1, vinflunine 280 mg/m(2) IV day 1 and erlotinib 75 mg PO days 2-21 ("continuous erlotinib") in 21 day cycles, two of four patients experienced DLTs. At dose level -1 (vinflunine 250 mg/m(2) every 21 days and erlotinib 75 mg/day), two of six patients experienced DLTs. The study was amended to enroll to "intermittent erlotinib" dosing: vinflunine day 1 and erlotinib days 2-15 of a 21 day cycle. Two of seven experienced DLTs and the study was terminated. One patient with breast cancer had a partial response; three had stable disease ≥ 6 cycles. All were treated in the continuous erlotinib group.

conclusionsGiven the marked toxicity in our patient population, the combination of vinflunine and erlotinib cannot be recommended for further study with these dosing schemas.

Indexed as

Drug Resistance, NeoplasmAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCytochrome P-450 CYP3ADose-Response Relationship, DrugErlotinib HydrochlorideFemaleHumansMaleMiddle AgedNeoplasmsPhenotypeQuinazolinesAntineoplastic AgentsCYP3A4 protein, humanCytochrome P-450 CYP3AErlotinib HydrochlorideQuinazolinesVinblastinevinflunine

Identifiers

PMID20387090
PMCPMC2988886
OpenAlexW2000768218

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.