NCT00003583

Brief Summary

RATIONALE: 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 to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer.

Trial Health

55
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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

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

June 1, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

April 30, 2004

Completed
Last Updated

December 4, 2013

Status Verified

May 1, 2006

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganLung CancerRadiation Toxicity

Keywords

limited stage small cell lung cancerdrug/agent toxicity by tissue/organradiation toxicity

Interventions

amifostine trihydrateDRUG
cisplatinDRUG
etoposideDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer Primary tumor must be evaluable radiographically PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2 times normal Renal: Creatinine less than 1.5 mg/dL Other: No concurrent active infection No prior malignancy except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No 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 (1)

University of Florida - Gainesville

Gainesville, Florida, 32610-0277, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLung NeoplasmsRadiation Injuries

Interventions

AmifostineCisplatinEtoposideRadiotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesTherapeutics

Study Officials

  • Dean L. McCarley, MD

    Veterans Affairs Medical Center - Gainesville

    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

April 30, 2004

Study Start

June 1, 1997

Last Updated

December 4, 2013

Record last verified: 2006-05

Locations

US(1)