Evidence map›Paper›PMID 30895346›Full record

ArticleCancer chemotherapy and pharmacology2019

A phase I study of gemcitabine + dasatinib (gd) or gemcitabine + dasatinib + cetuximab (GDC) in refractory solid tumors.

Niharika B Mettu, Donna Niedzwiecki, Christel Rushing, Andrew B Nixon, Jingquan Jia, Sherri Haley, Wanda Honeycutt, Herbert Hurwitz, Johanna C Bendell, Hope Uronis

Open access · greenAbstract readClinical Trial, Phase IComparative Study
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 24% 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

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Phase I trial of Ganitumab plus Dasatinib to Cotarget the Insulin-Like Growth Factor 1 Receptor and Src Family Kinase YES in Rhabdomyosarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  4. Review
  5. Article
  6. Review
  7. TargetingInternational journal of molecular sciences · 2020
    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

10 authors at 2 institutions in 1 country.

Niharika B MettuDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA. mettu002@mc.duke.edu.ORCID 0000-0002-7821-3298
Donna NiedzwieckiDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA.
Christel RushingDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA.
Andrew B NixonDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA.
Jingquan JiaDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA.
Sherri HaleyDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA.
Wanda HoneycuttDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA.
Herbert HurwitzGenentech-Roche, San Francisco, CA, USA.
Johanna C BendellSarah Cannon Research Institute, Nashville, TN, USA.
Hope UronisDuke University Medical Center, Seeley G. Mudd Bldg 10 Bryan Searle Drive, Box 3505, Durham, NC, 27710, USA.
Duke University · USSarah Cannon · US

Funding

Wound Angiogenesis as a Biomarker for Tumor AngiogenesisK24CA113755 · NCI · DUKE UNIVERSITY · PI HURWITZ, HERBERT I · 2006 to 2010
$613k
NCI NIH HHS K24 CA113755
6 · The paper itself

Abstract

purposeThis study was conducted to define the maximum tolerated dose (MTD), recommended phase two dose (RPTD), and toxicities of gemcitabine + dasatinib (GD) and gemcitabine + dasatinib + cetuximab (GDC) in advanced solid tumor patients.

methodsThis study was a standard phase I 3 + 3 dose escalation study evaluating two combination regimens, GD and GDC. Patients with advanced solid tumors were enrolled in cohorts of 3-6 to either GD or GDC. Gemcitabine was dosed at 1000 mg/m

resultsTwenty-five patients were enrolled, including 21 with pancreatic adenocarcinoma. Three patients received prior gemcitabine. Twenty-one patients were evaluable for toxicity and 16 for response. Four DLTs were observed: Grade (Gr) 3 neutropenia (GDC1, n = 1), Gr 3 ALT (GD2, n = 2), and Gr 5 pneumonitis (GDC2, n = 1). Possible treatment-emergent adverse events (TEAEs) in later cycles included: Gr 3-4 neutropenia (n = 7), Gr 4 colitis (n = 1), Gr 3 bilirubin (n = 2), Gr 3 anemia (n = 2), Gr 3 thrombocytopenia (n = 2), Gr 3 edema/fluid retention (n = 1), and Gr 3 vomiting (n = 3). Six of 16 patients (3 of whom were gemcitabine-refractory) had stable disease (SD) as best response, median duration = 5 months (range 1-7). One gemcitabine-refractory patient had a partial response (PR). Median PFS was 2.9 months (95% CI 2.1, 5.8). Median OS was 5.8 months (95% CI 4.1, 11.8). Dermal wound biopsies demonstrated that dasatinib resulted in a decrease of total and phospho-Src levels, and cetuximab resulted in a decrease of EGFR and ERBB2 levels.

conclusionsThe MTD/RPTD of GD is gemcitabine 1000 mg/m

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDasatinibDeoxycytidineDose-Response Relationship, DrugFemaleGemcitabineHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPancreatic NeoplasmsCetuximabDasatinibDeoxycytidineGemcitabineCetuximabDasatinibGemcitabinePancreatic cancerPhase I

Identifiers

PMID30895346
PMCPMC8040291
OpenAlexW2923341767

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.