NCT00004097

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced and/or recurrent head and neck cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

March 31, 2004

Completed
Last Updated

September 20, 2013

Status Verified

October 1, 2001

First QC Date

December 10, 1999

Last Update Submit

September 19, 2013

Conditions

Head and Neck Cancer

Keywords

stage III nasopharyngeal cancerstage IV nasopharyngeal cancerrecurrent nasopharyngeal canceruntreated metastatic squamous neck cancer with occult primaryrecurrent metastatic squamous neck cancer with occult primarystage III lip and oral cavity cancerstage IV lip and oral cavity cancerrecurrent lip and oral cavity cancerstage III hypopharyngeal cancerstage IV hypopharyngeal cancerrecurrent hypopharyngeal cancerstage III laryngeal cancerstage IV laryngeal cancerrecurrent laryngeal cancerstage III paranasal sinus and nasal cavity cancerstage IV paranasal sinus and nasal cavity cancerrecurrent paranasal sinus and nasal cavity cancerstage III oropharyngeal cancerstage IV oropharyngeal cancerrecurrent oropharyngeal cancer

Interventions

fluorouracilDRUG
gemcitabine hydrochlorideDRUG
paclitaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically proven head and neck cancer requiring regional radiotherapy Locoregional, recurrent disease after primary therapy with surgery, radiation, or both OR Stage IV, no prior therapy, and not amenable to conventional therapy with curative intent Metastatic disease allowed if predominant site and associated symptoms require local treatment in the head and neck region PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No significant infection No other severe medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from any prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Recovered from any prior radiotherapy Surgery: See Disease Characteristics Recovered from any prior surgery

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

Sponsors & Collaborators

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNasopharyngeal NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsOropharyngeal Neoplasms

Interventions

FluorouracilGemcitabinePaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesTherapeutics

Study Officials

  • Athanassios Argiris, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

December 10, 1999

First Posted

March 31, 2004

Study Start

August 1, 1999

Last Updated

September 20, 2013

Record last verified: 2001-10

Locations

US(2)