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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00528645 |
RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer Metastatic Cancer |
Drug: AZD0530 Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma |
Estimated Enrollment: | 44 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.
After completion of study therapy, patients are followed periodically for up to 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically confirmed small cell lung cancer
Extensive stage disease, defined as any of the following:
Cytologically confirmed malignant pleural effusion
No symptomatic, untreated, or uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
No second primary malignancy, except for carcinoma in situ of the cervix or nonmelanoma skin cancer, unless prior malignancy was diagnosed and treated ≥ 5 years with no subsequent evidence of recurrence
No concurrent severe and/or uncontrolled medical conditions, including any of the following:
No condition that impairs the ability to swallow AZD0530 tablets, including any of the following:
PRIOR CONCURRENT THERAPY:
Study Chair: | Julian Molina, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000563952, NCCTG-N0621 |
Study First Received: | September 10, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00528645 |
Health Authority: | United States: Food and Drug Administration |
extensive stage small cell lung cancer lung metastases malignant pleural effusion recurrent small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Pleural Effusion, Malignant Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Pleural Effusion Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Lung Diseases Neoplasm Metastasis Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplastic Processes Neoplasms Neoplasms by Histologic Type |
Pathologic Processes Neoplasms by Site Neoplasms, Nerve Tissue |