NCT00003582

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy and chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy and amifostine in treating patients who have stage II, stage III, or stage IV head and neck cancer that cannot be surgically removed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 1988

Longer than P75 for phase_1

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

May 1, 1988

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1996

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

8.6 years

First QC Date

November 1, 1999

Last Update Submit

December 14, 2016

Conditions

Carcinoma of Unknown PrimaryHead and Neck Cancer

Keywords

squamous cell carcinoma of unknown primarystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV 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 cavity

Interventions

amifostine trihydrateDRUG
cisplatinDRUG
fluorouracilDRUG
paclitaxelDRUG
quality-of-life assessmentPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck, including: Stage III or IV: oral cavity, paranasal sinus, hypopharynx, oropharynx, larynx, and nasopharynx OR Unknown primary carcinoma of the head and neck with greater than N1 disease if no planned neck dissection Evaluable disease No metastases below clavicle by clinical or radiographic diagnosis All hypopharynx and nasopharynx patients with N3 disease undergo a CT scan of the chest PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 130,000/mm3 WBC at least 3,400/mm3 Hemoglobin greater than 10.0 g/dL (transfusion allowed) Hepatic: Not specified Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No active heart disease No myocardial infarction within past 6 months No uncontrolled congestive heart failure No uncontrolled angina Cardiac ejection fraction at least 50% by MUGA scan for patients under 65 without antecedent heart disease, at least 55% for patients over 65 and/or with antecedent heart disease Pulmonary: FEV greater than 60% of predicted Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the treatment field Surgery: Eligible for PEG gastrostomy Other: At least 24 hours since prior antihypertensive and diuretic medications (prior to amifostine and chemotherapy regimens)

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

Sponsors & Collaborators

Study Sites (1)

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Neoplasms, Unknown PrimaryHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

AmifostineCisplatinFluorouracilPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Andre A. Abitbol, MD

    University of Miami Sylvester Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 16, 2004

Study Start

May 1, 1988

Primary Completion

December 1, 1996

Study Completion

December 1, 1996

Last Updated

December 15, 2016

Record last verified: 2016-12

Locations

US(1)