Recurrent Malignant Mesothelioma Clinical Trial
Official title:
Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma
This phase II trial is studying how well cediranib maleate works in treating patients with malignant mesothelioma that cannot be removed by surgery. Cediranib maleate 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
Status | Completed |
Enrollment | 51 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica vaginalis mesothelioma - Epithelial, sarcomatoid, or mixed subtype - International Mesothelioma Interest Group stage II-IV disease (for patients with pleural mesothelioma) - Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by conventional techniques OR > 10 mm by spiral CT scan - Pleural effusion and ascites are not considered measurable lesions - Disease not amenable to curative surgery - No known brain metastases - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100% - Life expectancy > 3 months - White blood cell (WBC) = 3,000/mm³ - Absolute neutrophil count = 1,500/mm³ - Hemoglobin = 8 g/dL - Platelets = 100,000/mm³ - Total bilirubin normal - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2.5 times upper limit of normal(ULN) - Creatinine normal OR creatinine clearance > 60 mL/min - Fertile patients must use effective contraception - Not pregnant or nursing - Negative pregnancy test - No history of allergic reactions to compounds of similar chemical or biologic composition to AZD2171 - Mean corrected QT interval (QTc) = 500 msec (with Bazett's correction) by EKG - No history of long QT syndrome - Proteinuria = 1+ on two consecutive dipsticks taken = 1 week apart - No other concurrent malignancy - No New York Heart Association class III or IV cardiac disease - No uncontrolled intercurrent illness including, but not limited to, any of the following: - Hypertension - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situations that would limit study compliance - No more than 1 prior cytotoxic chemotherapy - Prior intrapleural cytotoxic agents (including bleomycin) do not count towards prior cytotoxic chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered - No prior radiotherapy to the only site of measurable disease - At least 4 weeks since prior radiotherapy and recovered - At least 4 weeks since prior major surgery and recovered - More than 30 days since prior participation in an investigational trial - No prior treatment with a vascular endothelial growth factor (VEGF) inhibitor - No other concurrent investigational agents - No concurrent commercial agents for the malignancy - No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine) - No concurrent hematopoietic growth factors except epoetin alfa - No concurrent palliative radiotherapy - No combination antiretroviral therapy for HIV-positive patients - No concurrent drugs or biologics with proarrhythmic potential |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Campbell NP, Kunnavakkam R, Leighl N, Vincent MD, Gandara DR, Koczywas M, Gitlitz BJ, Agamah E, Thomas SP, Stadler WM, Vokes EE, Kindler HL. Cediranib in patients with malignant mesothelioma: a phase II trial of the University of Chicago Phase II Consorti — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate, Complete (CR) or Partial (PR) Response | 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. | Every 8 weeks | No |
Secondary | Changes in Laboratory Correlates | Examined using paired t-test or Wilcoxon signed-ranks test. | Baseline, days 15 and 29 of course 1, and then every 28 days | No |
Secondary | Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity | 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 HIF1a. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well. | Week 1 of course 1 | Yes |
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