Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00309946|
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : September 10, 2013
Last Update Posted : July 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Mesothelioma Epithelial Mesothelioma Localized Malignant Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma||Drug: cediranib maleate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Experimental: Treatment (enzyme inhibitor therapy)
Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
Drug: cediranib maleate
- Objective Response Rate, Complete (CR) or Partial (PR) Response [ Time Frame: Every 8 weeks ]Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
- Changes in Laboratory Correlates [ Time Frame: Baseline, days 15 and 29 of course 1, and then every 28 days ]Examined using paired t-test or Wilcoxon signed-ranks test.
- Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity [ Time Frame: Week 1 of course 1 ]Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309946
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Hedy Kindler||University of Chicago Comprehensive Cancer Center|