Evidence map›Paper›PMID 23553066›Full record

ArticleInvestigational new drugs2013

A Phase I study of the combination of oxaliplatin/docetaxel and vandetanib for the treatment of advanced gastroesophageal cancer.

Balazs Halmos, Yuxia Jia, Joseph A Bokar, Pingfu Fu, David J Adelstein, Rosalyn Juergens, Mary Beth Rodal, Afshin Dowlati

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00732745 (Phase I/II Study of the Combination of Oxaliplatin / Docetaxel and ZACTIMA for the Treatment of Advanced Cancers of the Esophagus and Gastroesophageal Junction), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 23% 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.

NCT00732745 phase1terminatednot on this map

Phase I/II Study of the Combination of Oxaliplatin / Docetaxel and ZACTIMA for the Treatment of Advanced Cancers of the Esophagus and Gastroesophageal Junction

TypeinterventionalSponsorCase Comprehensive Cancer CenterRan2008Enrolled9ConditionsAdenocarcinoma of the Gastroesophageal Junction, Esophageal CancerArmsdocetaxel, oxaliplatin, vandetanib, placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Effects of local irradiation combined with sunitinib on early remodeling, mitochondria, and oxidative stress in the rat heart.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2016
    Article
  5. Article
  6. 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

8 authors at 6 institutions in 1 country.

Balazs HalmosUniversity Hospitals, Seidman Cancer Center, Case Western Reserve University, Case Comprehensive Cancer Center, Cleveland, OH, USA, bh2376@columbia.edu.
Yuxia Jia
Joseph A Bokar
Pingfu Fu
David J Adelstein
Rosalyn Juergens
Mary Beth Rodal
Afshin Dowlati
Case Western Reserve University · USUniversity Hospitals Seidman Cancer Center · USCase Comprehensive Cancer CenterCleveland Clinic · USJohns Hopkins University · USNewYork–Presbyterian Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to assess the safety and tolerability of the multitargeted tyrosine kinase inhibitor, vandetanib (V), in combination with two chemotherapeutic agents, oxaliplatin (O) and docetaxel (D) in advanced gastroesophageal (GE) cancer.

methodsThis was a Phase I study (NCT00732745) with a standard 3+3 dose escalation design. The primary aim was to determine the optimal dose of the combination of vandetanib and OD chemotherapy.

resultsInitial treatment for the first cohort consisted of oxaliplatin at 100 mg/m2 on day 1, docetaxel at 35 mg/m2 on days 1 and 8 and vandetanib 100 mg PO daily of 21-day treatment cycles. As dose limiting toxicity (DLT) was reached in 2 out of 3 patients in cohort 1 (one grade 3 and one grade 4 diarrhea with dehydration), 6 patients were treated then at dose level -1 (O 80 mg/m2 on day 1, D 30 mg/m2 on days 1 and 8, V 100 mg PO daily days 1-21) in which no further DLTs were observed. This dose was established as maximum tolerated dose and is the recommended phase 2 dose. 8 out of 9 enrolled patients had adenocarcinoma. At dose level 1, 1 of the 3 patients had a documented partial response and 2 patients had stable disease. At dose level -1, 1 of 6 patients achieved a complete response, 2 of 6 patients had stable disease, and 3 of 6 patients had progressive disease.

conclusionsVandetanib added to oxaliplatin and docetaxel showed manageable toxicity and limited activity in advanced GE cancer.

Indexed as

AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDocetaxelDose-Response Relationship, DrugGastrointestinal NeoplasmsHumansMaleMaximum Tolerated DoseMiddle AgedOrganoplatinum CompoundsOxaliplatinPiperidinesProtein Kinase InhibitorsQuinazolinesAntineoplastic AgentsDocetaxelOrganoplatinum CompoundsOxaliplatinPiperidinesProtein Kinase InhibitorsQuinazolinesReceptors, Vascular Endothelial Growth FactorTaxoidsvandetanib

Identifiers

PMID23553066
OpenAlexW1964004965

What OpenQuestion holds

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Read underepoch 390

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.