Evidence map›Paper›PMID 26864210›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2016

A Phase I Clinical, Pharmacokinetic, and Pharmacodynamic Study of Weekly or Every Three Week Ixabepilone and Daily Sunitinib in Patients with Advanced Solid Tumors.

Alberto J Montero, Deukwoo Kwon, Aurea Flores, Krisztina Kovacs, Jonathan C Trent, Pasquale Benedetto, Caio Rocha-Lima, Jaime R Merchan

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

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 31% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

8 authors at 1 institution in 1 country.

Alberto J MonteroDepartment of Medicine, Division of Hematology-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida. jmerchan2@med.miami.edu montero2@ccf.org.
Deukwoo KwonBiostatistics and Bioinformatics Core, Sylvester Comprehensive Cancer Center, Miami, Florida.
Aurea FloresDepartment of Medicine, Division of Hematology-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida.
Krisztina KovacsDepartment of Medicine, Division of Hematology-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida.
Jonathan C TrentDepartment of Medicine, Division of Hematology-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida.
Pasquale BenedettoDepartment of Medicine, Division of Hematology-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida.
Caio Rocha-LimaDepartment of Medicine, Division of Hematology-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida.
Jaime R MerchanDepartment of Medicine, Division of Hematology-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida. jmerchan2@med.miami.edu montero2@ccf.org.
Sylvester Comprehensive Cancer Center · US

Funding

Biomarkers for VEGF and mTOR Blockade in Advanced Renal CancerR21CA119545 · NCI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI MERCHAN, JAIME R · 2006 to 2007
$452k
NCI NIH HHS R21 CA119545
6 · The paper itself

Abstract

purposeTo evaluate the safety, MTD, pharmacokinetics/pharmacodynamics, and early clinical activity of ixabepilone given either weekly or every 3 weeks in combination with daily sunitinib in patients with advanced solid tumors. EXPERIMENTAL

designEligible patients received either weekly (schedule A) or every 3 weeks (schedule B) ixabepilone at escalating doses (schedule A: 7.5, 15, or 20 mg/m(2); schedule B: 20, 30, or 40 mg/m(2)), and oral sunitinib (37.5 mg daily), starting on day 8 of cycle 1. Dose-limiting toxicities (DLT) were assessed during cycle 1.

resultsThe ixabepilone and sunitinib combination was fairly well tolerated. DLTs were observed in 3 subjects (1 in schedule 3A and 2 in schedule 3B). The most common grade 3-4 hematologic and nonhematologic adverse events were leukopenia and fatigue, respectively. Four patients (3 in schedule A) achieved a partial response, while 13 patients had stable disease. Nine of 17 heavily pretreated colorectal cancer patients had clinical benefit. Coadministration of sunitinib with ixabepilone on a weekly (but not every 3 week) schedule was associated with a significant increase in the half-life and a significant decrease in the clearance of ixabepilone. Correlative studies demonstrated a significant association between higher baseline plasma angiogenic activity (PAA) and clinical benefit in schedule A patients. Weekly, but not every 3 weeks, ixabepilone led to a significant decrease in PAA postbaseline.

conclusionsCoadministration of ixabepilone with sunitinib has acceptable toxicity and encouraging clinical activity in heavily pretreated patients, particularly in patients with metastatic colorectal cancer. Clin Cancer Res; 22(13); 3209-17. ©2016 AACR.

Indexed as

AdultAgedAngiogenesis InhibitorsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDrug Administration ScheduleEpothilonesFemaleHumansIndolesMaleMiddle AgedNeoplasmsNeovascularization, PathologicPyrrolesAngiogenesis InhibitorsAntineoplastic AgentsBiomarkers, TumorEpothilonesIndolesixabepilonePyrrolesSunitinibTubulin Modulators

Identifiers

PMID26864210
PMCPMC4930738
OpenAlexW2288864420

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.