NCT00004176

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. 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 plus chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 1998

Geographic Reach
1 country

4 active sites

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

October 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

May 25, 2004

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

2.3 years

First QC Date

January 21, 2000

Last Update Submit

May 14, 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 confined to one hemithorax Measurable disease No pleural effusion(s) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and alkaline phosphatase no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal (8.9-10.3 mg/dL) Cardiovascular: No history of congestive heart failure or myocardial infarction within the past 6 months No uncontrolled or unexplained rhythm disturbance or symptoms of unstable ischemic heart disease Other: Not pregnant Fertile patients must use effective contraception No prior or concurrent malignancy within the past 5 years, except: Basal or squamous cell skin cancer Carcinoma in situ of the cervix No concurrent infection No significant uncontrolled hyponatremia No other significant concurrent medical or psychiatric illness which would preclude compliance No antecedent hearing loss Afebrile for at least 3 days unless fever due to tumor or obstructive pneumonia PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No drugs that could potentiate nephrotoxicity of cisplatin (e.g., aminoglycosides or lithium)

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

Sponsors & Collaborators

Study Sites (4)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, 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

  • William H. Read, M.D.

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

May 25, 2004

Study Start

October 1, 1998

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations

US(4)