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Tracking Information | |||||||||||||
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First Received Date † | July 26, 2005 | ||||||||||||
Last Updated Date | April 14, 2009 | ||||||||||||
Start Date † | January 2006 | ||||||||||||
Current Primary Outcome Measures † |
11-month survival rate [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00124618 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||||||
Brief Title † | Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer | ||||||||||||
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 | ||||||||||||
Brief Summary | 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 | 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 |
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Study Phase | Phase II | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Open Label | ||||||||||||
Condition † | Lung Cancer | ||||||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Estimated Enrollment † | 60 | ||||||||||||
Completion Date | |||||||||||||
Estimated Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00124618 | ||||||||||||
Responsible Party | Jan C. Buckner, North Central Cancer Treatment Group | ||||||||||||
Secondary IDs †† | NCCTG-N0422 | ||||||||||||
Study Sponsor † | North Central Cancer Treatment Group | ||||||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | January 2009 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |