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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00368992 |
RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, 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. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with paclitaxel, carboplatin, and bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab works in treating patients with advanced non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Biological: bevacizumab Biological: cetuximab Drug: carboplatin Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 90 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced primary non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
Newly diagnosed selected stage IIIB disease
Newly diagnosed stage IV disease
Any 1 of the following cellular types:
Measurable or nonmeasurable disease as measured by CT scan, MRI, x-ray, or physical exam
PATIENT CHARACTERISTICS:
No history of any of the following:
No other prior malignancy within the past 5 years except for the following:
PRIOR CONCURRENT THERAPY:
No concurrent full-dose anticoagulation therapy
Study Chair: | Edward S. Kim | M.D. Anderson Cancer Center |
Investigator: | Roy S. Herbst, MD, PhD | M.D. Anderson Cancer Center |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000495363, SWOG-S0536 |
Study First Received: | August 24, 2006 |
Last Updated: | June 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00368992 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer large cell lung cancer adenocarcinoma of the lung |
Thoracic Neoplasms Cetuximab Antimitotic Agents Carboplatin Bevacizumab Angiogenesis Inhibitors Recurrence Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances |
Cetuximab Mitosis Modulators Carboplatin Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |