NCT00003580

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. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of treatment in patients receiving radiation therapy and cisplatin for advanced head and neck cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1998

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2004

Completed
Last Updated

June 26, 2013

Status Verified

May 1, 2006

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganHead and Neck CancerOral ComplicationsRadiation Toxicity

Keywords

oral complicationsstage 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 larynxdrug/agent toxicity by tissue/organradiation toxicity

Interventions

amifostine trihydrateDRUG
cisplatinDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx Previously untreated Stage III or IV No distant metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 61 mL/min Other: No history of any underlying medical or psychiatric illness Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: No prior therapy for head and neck cancer Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 24 hours since prior 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)

William F. Bowld Hospital

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsHead and Neck NeoplasmsRadiation InjuriesSquamous Cell Carcinoma of Head and Neck

Interventions

AmifostineCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by SiteNeoplasmsWounds and InjuriesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • K. Thomas Robbins, MD

    University of Florida

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 25, 2004

Study Start

June 1, 1998

Study Completion

May 1, 2004

Last Updated

June 26, 2013

Record last verified: 2006-05

Locations

US(1)