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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00124618 |
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 |
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Lung Cancer |
Biological: cetuximab Radiation: radiation therapy |
Phase II |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000435991, NCCTG-N0422 |
Study First Received: | July 26, 2005 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00124618 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Cetuximab |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Cetuximab Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |