NCT00004901

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 more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced mouth cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Typical duration for phase_1 head-and-neck-cancer

Geographic Reach
1 country

2 active sites

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

October 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
Last Updated

June 26, 2013

Status Verified

August 1, 2000

First QC Date

March 7, 2000

Last Update Submit

June 25, 2013

Conditions

Head and Neck Cancer

Keywords

stage IV hypopharyngeal cancerrecurrent hypopharyngeal cancerstage IV squamous cell carcinoma of the lip and oral cavitystage IV verrucous carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavityrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent verrucous carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavitystage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynx

Interventions

ethynyluracilDRUG
fluorouracilDRUG
hydroxyureaDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced malignant oral or laryngeal neoplasm requiring regional radiotherapy and not amenable to standard therapy Tumor site amenable to radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Expected 2 year survival less than 10% in previously untreated patients Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine clearance at least 50 mL/min Other: No severe infection or medical illness that would preclude study Must be able to swallow and retain oral medications Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Not specified

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, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsHypopharyngeal NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

eniluracilFluorouracilHydroxyureaRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesOrganic ChemicalsTherapeutics

Study Officials

  • Everett E. Vokes, MD

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

July 26, 2004

Study Start

October 1, 1999

Study Completion

July 1, 2004

Last Updated

June 26, 2013

Record last verified: 2000-08

Locations

US(2)