|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00436332 |
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: bevacizumab Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC) |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2007 |
| Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g., adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the following criteria:
Disease staged as 1 of the following:
Stage IV disease (any T, any N, M1 [distant metastases present])
Measurable or nonmeasurable disease by chest CT scan
PATIENT CHARACTERISTICS:
No other prior malignancy except for any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 170 Study Locations| Study Chair: | Howard L. West, MD | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
More Information
| Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
| Study ID Numbers: | CDR0000529756, SWOG-S0635 |
| Study First Received: | February 15, 2007 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00436332 History of Changes |
| Health Authority: | Unspecified |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer bronchoalveolar cell lung cancer adenocarcinoma of the lung |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Protein Kinase Inhibitors Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Erlotinib |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Adenocarcinoma, Bronchiolo-Alveolar Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |