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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118183 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with either cetuximab or bortezomib may be effective as first-line therapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with either cetuximab or bortezomib works as first-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: bortezomib Drug: cetuximab Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Docetaxel Plus Cetuximab and Docetaxel Plus Bortezomib (NSC #681239, IND #58443) in Advanced Non-Small Cell Lung Cancer Patients With Performance Status (PS) 2 |
Estimated Enrollment: | 62 |
Study Start Date: | July 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed monthly for 1 year, every 2 months for 2 years, and then every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 62 patients (31 per treatment arm) will be accrued for this study within 6-11 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), including any of the following cellular subtypes:
Meets 1 of the following stage criteria:
Stage IIIB disease with a malignant pleural effusion or supraclavicular node involvement
Measurable or nonmeasurable disease
The following are considered nonmeasurable disease:
No untreated CNS metastases
Patients with known CNS metastases who have received prior therapy (e.g., surgery, radiotherapy, or gamma knife radiosurgery) are eligible provided both of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Rogerio C. Lilenbaum, MD | Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center |
Study ID Numbers: | CDR0000433338, CALGB-30402 |
Study First Received: | July 8, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00118183 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the lung adenosquamous cell lung cancer large cell lung cancer squamous cell lung cancer |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Cetuximab Bortezomib Recurrence Carcinoma Docetaxel |
Adenocarcinoma of lung Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |