Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery (NCT00309946) | Clinical Trial Compass
CompletedPhase 2
Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
United States51 participantsStarted 2005-12
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 uncontroll…
What they're measuring
1
Objective Response Rate, Complete (CR) or Partial (PR) Response