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Cetuximab and Radiation Thera...

Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Last Updated: 2016-07-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2015-03-31

Brief Summary

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RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.

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Detailed Description

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OBJECTIVES:

Primary

\* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy.

Secondary

* Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine whether fear of death is less severe in the oldest of patients treated with this regimen.
* Determine whether fear of death predicts survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months

Conditions

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Lung Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cetuximab/Radiation

Cetuximab (C225) and Radiation

Group Type EXPERIMENTAL

cetuximab

Intervention Type BIOLOGICAL

radiation therapy

Intervention Type RADIATION

Interventions

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cetuximab

Intervention Type BIOLOGICAL

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

* Stage IIIA or IIIB disease
* Must be a candidate for curative radiotherapy
* Not a candidate for other concurrent chemotherapy and radiotherapy
* No surgical treatment available
* No pleural effusion suspected or proven to be malignant
* No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days

PATIENT CHARACTERISTICS:

Age \* 18 and over

Performance status

* Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
* ECOG 2 (age 18 to 64 years)

Life expectancy

\* At least 12 weeks

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL

Hepatic

* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 3 times ULN

Renal

* Creatinine ≤ 1.5 times ULN

Pulmonary

* FEV\_1 ≥ 1 L
* No idiopathic pulmonary fibrosis

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Magnesium normal
* No uncontrolled infection
* No other severe underlying disease that would preclude study entry
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
* No major psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

\* Not specified

Chemotherapy

* See Disease Characteristics
* No prior chemotherapy for NSCLC

Endocrine therapy

\* Not specified

Radiotherapy

* No prior therapeutic radiotherapy to the chest
* No concurrent intensity modulated radiotherapy

Other

\* No prior epidermal growth factor receptor inhibitors

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

St. Anthony's Memorial Hospital

Effingham, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Valley Cancer Center

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status