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 range
18 Years
Sex
ALL
See this in plain English?
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.