Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Southwest Oncology Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00268489 |
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, 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 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: bevacizumab Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment) |
Estimated Enrollment: | 46 |
Study Start Date: | May 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 46 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 diagnosed stage IIIB or IV non-small cell lung cancer
Stage IIIB patients must have pleural effusion
Must have measurable disease with at least one lesion with a longest diameter accurately measured as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with spiral CT
Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels should receive palliative radiation
No symptomatic, untreated, or uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
No active or recent history of hemoptysis
PRIOR CONCURRENT THERAPY:
No full field radiation therapy within the past 4 weeks or limited field radiation therapy within the past 2 weeks
No concurrent anticoagulant use
Study Chair: | Alex A. Adjei, MD, PhD | Roswell Park Cancer Institute |
Investigator: | Donald B. Wender, MD, PhD | St. Luke's Regional Medical Center |
Study Chair: | Ralph G. Zinner, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000456427, NCCTG-N0426, SWOG-N0426 |
Study First Received: | December 20, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00268489 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer squamous cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Bevacizumab Recurrence Carcinoma Pemetrexed Folic Acid |
Pleural Effusion Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |