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

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00124618

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: cetuximab Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

11-month survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival time [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Tumor response (complete and partial) [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]
Time to treatment failure [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2006
Estimated Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Surgery

Not specified

Other

No prior epidermal growth factor receptor inhibitors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124618

Show 175 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Aminah Jatoi, MD	Mayo Clinic
Investigator:	Steven E. Schild, MD	Mayo Clinic Scottsdale
Investigator:	George T. Henning, MD	Saint Joseph Mercy Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000435991, NCCTG-N0422
Study First Received:	July 26, 2005
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00124618
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Cetuximab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009