NCT00003251

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 x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy. PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

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

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 13, 2004

Completed
Last Updated

December 4, 2013

Status Verified

June 1, 2000

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganHead and Neck CancerRadiation Toxicity

Keywords

stage III nasopharyngeal cancerstage IV nasopharyngeal cancerrecurrent nasopharyngeal cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancersalivary gland squamous cell carcinomahigh-grade salivary gland mucoepidermoid carcinomastage 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 cancerstage III squamous cell carcinoma of the lip and oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage IV mucoepidermoid carcinoma of the oral cavityrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent mucoepidermoid carcinoma of the oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitydrug/agent toxicity by tissue/organradiation toxicity

Interventions

amifostine trihydrateDRUG
cisplatinDRUG
paclitaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck Unresectable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 2.5 times normal SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: No other significant infection No other medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months since prior radiotherapy (patients with recurrent disease) to head and neck region Surgery: Not speciified Other: At least 24 hours since antihypertensive medication

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 Illinois at Chicago Health Sciences Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsHead and Neck NeoplasmsRadiation InjuriesNasopharyngeal NeoplasmsSalivary Gland NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsOropharyngeal NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

AmifostineCisplatinPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by SiteNeoplasmsWounds and InjuriesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesSalivary Gland DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Fred R. Rosen, MD

    University of Illinois at Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 13, 2004

Study Start

December 1, 1997

Last Updated

December 4, 2013

Record last verified: 2000-06

Locations

US(1)