S0509: AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma|
- Overall response rate (complete response and partial response) [ Time Frame: 3 years or until death ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 years or until death ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 3 years or until death ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Every 8 weeks until progression ] [ Designated as safety issue: No ]
- Relationship between molecular/genetic correlates of the angiogenesis pathway with survival and response [ Time Frame: At week 1, week 8 and week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Drug: cediranib maleate
45 mg/day by mouth, Days 1 - 28, Daily. There will be no pause between cycles.
- Determine the objective confirmed, complete, and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171.
- Determine the clinical benefit, in terms of objective response and stable disease rates, in patients treated with this drug.
- Determine the 1-year median overall survival and progression-free survival in patients treated with this drug.
- Determine the frequency and severity of toxic effects in patients treated with this drug.
- Correlate, preliminarily, pre- and post-treatment plasma vascular endothelial growth factor and soluble vascular cell adhesion molecule with clinical outcomes in patients treated with this drug.
- Correlate, preliminarily, circulating endothelial cells with clinical outcomes in patients treated with this drug.
- Correlate variants of genes in the pathway targeted by this drug and variants of genes involved in the development of hypertension with the antiangiogenic property of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years from study entry.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243074
Show 90 Study Locations
|Study Chair:||Linda Garland, MD||University of Arizona|
|Study Chair:||Antoinette J. Wozniak, MD||Barbara Ann Karmanos Cancer Institute|