S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed B… (NCT00243074) | Clinical Trial Compass
CompletedPhase 2
S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
United States54 participantsStarted 2005-11
Plain-language summary
This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. 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
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 confirmed epithelial, sarcomatous, or biphasic malignant pleural mesothelioma
* Unresectable disease
* Residual disease after prior cytoreductive surgery allowed
* Measurable disease by CT scan or MRI
* Prior treatment with platinum-based chemotherapy required
* No known CNS metastasis
* Performance status
* Zubrod 0-2
* WBC \>= 3,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* AST or ALT =\< 1.5 times upper limit of normal (ULN)
* Bilirubin normal
* Creatinine =\< 1.5 times ULN OR
* Creatinine clearance \>= 50 mL/min
* Proteinuria =\< 1+ by 2 consecutive dipstick tests taken \>= 1 week apart
* No history of familial long QT syndrome
* Mean QTc =\< 470 msec
* Systolic BP =\< 150 mm Hg AND diastolic BP =\< 100 mm Hg
* Must have New York Heart Association class I or II disease
* Class II must be controlled with treatment
* Able to swallow and/or receive enteral medications via gastrostomy feeding tube
* Not requiring IV alimentation
* No active peptic ulcer
* No intractable nausea or vomiting
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in remission
* No history of hypersensitivity reaction to compounds of similar chemical or biological composition to the study drug
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What they're measuring
1
Overall Response Rate
Timeframe: Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.