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Study 17 of 2264 for search of: | United States, Kansas |
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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103207 |
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.
PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features |
Estimated Enrollment: | 71 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | April 2009 (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 once on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 9-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features meeting 1 of the following stage criteria:
Measurable disease
No untreated brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
HIV-positive patients are eligible provided the following criteria are met:
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Chandra P. Belani, MD | Milton S. Hershey Medical Center |
Study Chair: | Suresh Ramalingam, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000409755, ECOG-E1504 |
Study First Received: | February 7, 2005 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00103207 |
Health Authority: | United States: Federal Government |
bronchoalveolar cell lung cancer adenocarcinoma of the lung stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma of lung Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms |
Lung Diseases Cetuximab Adenocarcinoma Carcinoma, Non-Small-Cell Lung Recurrence Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |