Evidence map›Paper›PMID 24709487›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2014

Randomised phase II study of docetaxel plus vandetanib versus docetaxel followed by vandetanib in patients with persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: SWOG S0904.

Robert L Coleman, James Moon, Anil K Sood, Wei Hu, James E Delmore, Albert J Bonebrake, Garnet L Anderson, Setsuko K Chambers, Maurie Markman

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00872989 (Randomized Phase II Study of Docetaxel Followed by Vandetanib), which is not on this map. Cited by 11 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 6 pooled it
6.0field-weighted citation impact, top 4% 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.

NCT00872989 phase2completednot on this map

Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2010 to 2014Enrolled129ConditionsFallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity CancerArmsdocetaxel, vandetanib
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 6 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Pooled it
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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

9 authors at 6 institutions in 1 country.

Robert L ColemanUniversity of Texas, M.D. Anderson Cancer Center, Houston, TX, USA. Electronic address: rcoleman@mdanderson.org.
James MoonSWOG Statistical Center, Seattle, WA, USA.
Anil K SoodUniversity of Texas, M.D. Anderson Cancer Center, Houston, TX, USA.
Wei HuUniversity of Texas, M.D. Anderson Cancer Center, Houston, TX, USA.
James E DelmoreWichita CCOP/Associates in Women's Health, Wichita, KS, USA.
Albert J BonebrakeCancer Research for the Ozarks-Cox Health, Springfield, MO, USA.
Garnet L AndersonSWOG Statistical Center, Seattle, WA, USA; Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Setsuko K ChambersArizona Cancer Center, Tucson, AZ, USA.
Maurie MarkmanCancer Treatment Centers of America, Zion, IL, USA.
The University of Texas MD Anderson Cancer Center · USCancer Research And Biostatistics · USArizona Oncology · USAssociates in Women’s Health · USCancer Treatment Centers of America · USCoxHealth · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Jesse Nodora · 1985 to 2026
$124.9M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Catherine M. Tangen · 2014 to 2026
$115.2M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
UNIVERSITY OF TEXAS MD ANDERSON SPORE IN OVARIAN CANCERP50CA083639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BAST, ROBERT C · 1999 to 2015
$33.0M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1UG1CA233329 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KELLY K HUNT, CHELSEA Camille PINNIX · 2019 to 2026
$11.1M
SOUTHERN NEVADA CANCER RESEARCH FOUNDATION-CCOPU10CA035421 · NCI · SOUTHERN NEVADA CANCER RESEARCH FDN · PI ELLERTON, JOHN A · 1985 to 2014
$9.8M
NCATS NIH HHS UL1 TR000371NCI NIH HHS CA105409NCI NIH HHS CA16385NCI NIH HHS CA20319NCI NIH HHS CA35128NCI NIH HHS CA35421NCI NIH HHS CA37981NCI NIH HHS CA42777NCI NIH HHS CA45461NCI NIH HHS CA45808NCI NIH HHS CA46282NCI NIH HHS CA58723NCI NIH HHS CA58882NCI NIH HHS CA76132NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA067575NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA023100NCI NIH HHS P50 CA083639NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035421NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037981NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045461NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA105409NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA233329NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundVandetanib is an oral tyrosine kinase inhibitor of VEGFR-2/3, EGFR and RET, which has demonstrated clinical activity as a single agent and in combination with taxanes. We explored the efficacy, safety and toxicity of docetaxel and vandetanib in women with recurrent ovarian cancer (OC).

methodsWomen with refractory or progressive OC were randomised 1:1 to docetaxel (75 mg/m(2), IV)+vandetanib (100mg daily, PO, D+V) or docetaxel (75 mg/m(2), D). Up to three additional cytotoxic regimens for recurrence and prior anti-angiogenic agents (as primary therapy) were allowed. The primary end-point was progression free survival (PFS). The study had 84% power to detect a PFS hazard ratio of 0.65, using a one-sided P of 0.1. This corresponds to an increase in median PFS from 3.6 months to 5.6 months. Patients progressing on D were allowed to receive single agent vandetanib (D → V).

results131 Patients were enrolled; two were excluded. 16% had received prior anti-angiogenic therapy. The median PFS estimates were 3.0 mos (D+V) versus 3.5 (D); HR: 0.99 (80% CI: 0.79-1.26). 61 Patients on D+V were assessable for toxicity; 20(33%) had treatment-related Grade (G) 4 events, primarily haematologic. Similarly, 17 (27%) of 64 patients receiving D had G4 events, primarily haematologic. 27 Evaluable patients crossed-over to V. 1/27(4%) experienced a G4 event. G3 diarrhoea was observed in 4% D → V patients. Median OS was 14 mos (D+V) versus 18 mos (D → V); HR(OS): 1.25 (80% CI: 0.93-1.68). Crossover vandetanib response was 4% (1/27 evaluable patients). High plasma IL-8 levels were associated with response to D+V.

conclusionsCombination docetaxel+vandetanib did not prolong PFS relative to docetaxel alone in OC patients. No unexpected safety issues were identified.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Ovarian EpithelialDisease-Free SurvivalDocetaxelFallopian Tube NeoplasmsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPeritoneal NeoplasmsBiomarkers, TumorDocetaxelPiperidinesQuinazolinesTaxoidsvandetanibChemotherapyClinical trialEpithelial cancerFallopian tube cancerOvarian cancerPrimary peritoneal cancerRandomised phase IITaxanesVandetanib

Identifiers

PMID24709487
PMCPMC4098779
OpenAlexW2118461028

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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.