NCT00004094

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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated advanced cancer of the mouth, pharynx, or larynx.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

4 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
3.4 years until next milestone

First Posted

Study publicly available on registry

May 8, 2003

Completed
Last Updated

January 6, 2014

Status Verified

December 1, 2002

First QC Date

December 10, 1999

Last Update Submit

January 3, 2014

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynx

Interventions

carboplatinDRUG
fluorouracilDRUG
hydroxyureaDRUG
paclitaxelDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell or poorly differentiated carcinomas, or lymphoepithelioma of the head and neck * Stage III carcinoma of the base of the tongue or hypopharynx * Stage IV carcinoma of the oral cavity, pharynx (including nasopharynx, oropharynx, and hypopharynx), or larynx * No distant metastasis * Measurable disease desirable * Clinically disease free after prior surgery allowed PATIENT CHARACTERISTICS: Age: * 15 to 80 Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No clinically significant cardiomyopathy or congestive heart failure Pulmonary: * No clinically significant pulmonary dysfunction Other: * No severe baseline neurologic deficits * No uncontrolled active infection other than that not curable without treatment of cancer * No sensitivity to Cremophor EL * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics * Incisional or excisional biopsy and organ sparing procedures (e.g., debulking of airway compromising tumors or neck dissection) in patients with an existing primary tumor allowed * No more than 3 months since prior nonbiopsy procedure

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

Sponsors & Collaborators

Study Sites (4)

Monroe Medical Associates

Chicago, Illinois, 60603, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CarboplatinFluorouracilHydroxyureaPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Athanassios Argiris, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 8, 2003

Study Start

August 1, 1999

Last Updated

January 6, 2014

Record last verified: 2002-12

Locations

US(4)