PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That … (NCT00365053) | Clinical Trial Compass
CompletedPhase 2
PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
United States13 participantsStarted 2006-06
Plain-language summary
This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 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 or cytologically confirmed malignant pleural mesothelioma (MPM) of any of the following subtypes:
* Epithelial
* Sarcomatoid
* Mixed
* Have received only 1 prior systemic chemotherapy regimen for advanced mesothelioma
* Prior intrapleural cytotoxic agents (including bleomycin) not considered systemic chemotherapy
* Patients who are not candidates for combination chemotherapy are eligible even if they have not received prior chemotherapy
* Unresectable disease
* Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
* The sole site of measurable disease must not be located within the radiotherapy port
* No known brain metastases
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 3 months
* WBC \>= 3,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Bilirubin normal
* AST/ALT =\< 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance \>= 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-barrier contraception for 1 week before, during, and for \>= 2 weeks after completion of study treatment
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
* No symptomatic congestive heart failure
* No congestive heart failure related to primary cardiac…
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
Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee