NCT00005590

Brief Summary

RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if levofloxacin if effective in preventing infection. PURPOSE: Randomized phase III trial to determine the effectiveness of levofloxacin in preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2002

First QC Date

May 2, 2000

Last Update Submit

August 1, 2013

Conditions

Brain and Central Nervous System TumorsBreast CancerExtragonadal Germ Cell TumorInfectionLung CancerLymphomaOvarian CancerSmall Intestine CancerTesticular Germ Cell TumorUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent breast cancerrecurrent adult Hodgkin lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomalimited stage small cell lung cancerextensive stage small cell lung cancerrecurrent small cell lung cancersmall intestine lymphomastage II malignant testicular germ cell tumorstage III malignant testicular germ cell tumorunspecified adult solid tumor, protocol specificstage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomastage II ovarian germ cell tumorstage III ovarian germ cell tumorstage IV ovarian germ cell tumorstage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaextragonadal germ cell tumoradult central nervous system germ cell tumorprimary central nervous system non-Hodgkin lymphomainfectionintraocular lymphomastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromecontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage II small lymphocytic lymphomastage II marginal zone lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

levofloxacinDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of solid tumor, including but not limited to, the following: * Stage II-IV germ cell malignancy * Small cell lung cancer * Recurrent breast cancer OR * Diagnosis of lymphoma * About to start a program of antineoplastic chemotherapy for malignant disease that will regularly induce myelosuppression with a risk of temporary severe neutropenia (i.e., neutrophil count less than 500/mm3), but does not routinely require filgrastim (G-CSF) or stem cell support * Not previously randomized into the Significant trial for a different multicourse chemotherapy program * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 16 and over Sex: * Not specified Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Creatinine normal OR * Creatinine clearance greater than 40 mL/min Other: * Not pregnant or nursing * Fertile patients must use effective contraception in addition to oral contraceptive pills * HIV negative * No epilepsy * No history of adverse events resulting from fluoroquinolone therapy (e.g., allergy or tendinitis) * No concurrent use of a sunbed or exposure to strong sunlight PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent antibacterial therapy * No other concurrent prophylactic antibacterial agents including cotrimoxazole prophylaxis against Pneumocystis carinii * No iron supplements, sucralfate, or mineral antacids 2 hours before or after study medication * Concurrent entry into other clinical trials allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Related Publications (1)

  • Cullen M, Steven N, Billingham L, Gaunt C, Hastings M, Simmonds P, Stuart N, Rea D, Bower M, Fernando I, Huddart R, Gollins S, Stanley A; Simple Investigation in Neutropenic Individuals of the Frequency of Infection after Chemotherapy +/- Antibiotic in a Number of Tumours (SIGNIFICANT) Trial Group. Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. N Engl J Med. 2005 Sep 8;353(10):988-98. doi: 10.1056/NEJMoa050078.

    PMID: 16148284RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBreast NeoplasmsInfectionsLung NeoplasmsLymphomaOvarian NeoplasmsTesticular Germ Cell TumorHodgkin DiseaseLymphoma, T-Cell, CutaneousSmall Cell Lung CarcinomaTesticular NeoplasmsLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersLymphoma, T-CellCarcinoma, BronchogenicBronchial NeoplasmsGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsEye NeoplasmsLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP

    University Hospital Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

August 1, 1999

Study Completion

September 1, 2005

Last Updated

August 2, 2013

Record last verified: 2002-07

Locations

GB(1)