Evidence map›Paper›PMID 24166832›Full record

Trial reportHead & neck2014

Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329.

Binu Malhotra, James Moon, Omar Kucuk, Joseph I Clark, Susan G Urba, Gregory T Wolf, Francis P Worden

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Head & neck, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. 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

7 authors.

Binu MalhotraDepartment of Hematology Oncology, University of Michigan, Ann Arbor, Michigan.
James Moon
Omar Kucuk
Joseph I Clark
Susan G Urba
Gregory T Wolf
Francis P Worden

Funding

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
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
UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
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
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
WESTERN ONCOLOGY RESEARCH CONSORTIUMU10CA045377 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI CONLIN, ALISON K · 1987 to 2013
$9.9M
Hawaii Minority-Based Clinical Community Oncology ProgramU10CA063844 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI BERENBERG, JEFFREY LEE · 1994 to 2014
$9.0M
Montana Cancer Consortium CCOPU10CA067575 · NCI · MONTANA CANCER CONSORTIUM · PI MARCHELLO, BENJAMIN T. · 1995 to 2013
$6.5M
NCI NIH HHS CA12644NCI NIH HHS CA14028NCI NIH HHS CA16385NCI NIH HHS CA20319NCI NIH HHS CA22433NCI NIH HHS CA45377NCI NIH HHS CA45808NCI NIH HHS CA46282NCI NIH HHS CA52654NCI NIH HHS CA76447NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA063844NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA052654NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA076447NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180835NCI NIH HHS U10 CA180888NCRR NIH HHS UL1 RR024131
6 · The paper itself

Abstract

backgroundA phase I study and an institutional pilot study in patients with metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) utilizing biweekly gemcitabine and paclitaxel (GEMTAX), showed an overall response rate of 53%. 1 This phase II trial was conducted to determine the feasibility, tolerability, and efficacy of this combination.

methodsPatients with metastatic/recurrent SCCHN were treated with gemcitabine (3000 mg/m2) and paclitaxel (150 mg/m2) on days 1 and 15 of every 28-day cycle.

resultsIn 57 patients with measurable disease, median progression-free survival (PFS) was 4 months and median overall survival (OS) was 8 months. Overall response rate of 28% and disease stabilization in 19% were seen. There were no treatment-related deaths with grade 3/4 hematologic toxicity seen in 20% of the patients.

conclusionBiweekly GEMTAX is feasible, well tolerated, and demonstrated reasonable efficacy. This may be an alternative for patients who are not candidates for platinum-based chemotherapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Squamous CellDeoxycytidineDisease-Free SurvivalDrug Administration ScheduleFeasibility StudiesFemaleGemcitabineHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntineoplastic AgentsDeoxycytidineGemcitabinePaclitaxelgemcitabinemetastaticpaclitaxelrecurrentsquamous cell carcinoma of the head and neck

Identifiers

PMID24166832
PMCPMC4640463

What OpenQuestion holds

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Registered trials

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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.