AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma (NCT01105390) | Clinical Trial Compass
WithdrawnPhase 2
AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma
Stopped: withdrawn
0Started 2010-04
Plain-language summary
This phase II trial is studying how well giving AMG 102 together with pemetrexed disodium and cisplatin works in treating patients with malignant pleural mesothelioma. Monoclonal antibodies, such as AMG 102, can block tumor growth in different ways. Some block the ability of tumor cells to grow or spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AMG 102 together with pemetrexed disodium and cisplatin may kill more tumor cells
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 and cytologically confirmed malignant mesothelioma of the pleura
* All subtypes allowed
* Disease not amenable to curative surgery
* Measurable disease
* Patients with disease not measurable by standard RECIST criteria (i.e., pleural rinds/thickening only) allowed
* Pleural effusions or positive bone scans are not considered measurable
* No prior radiotherapy to the target lesion or measurable lesion unless the site has subsequent evidence of progression
* Patients who have undergone pleurodesis allowed
* Post-pleurodesis CT scan required
* No known or suspected brain metastases
* ECOG performance status 0-1
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 1.5 times ULN
* ALT and AST ≤ 1.5 times ULN
* Albumin ≥ 2.5 g/dL
* Creatinine clearance ≥ 45 mL/min OR serum creatinine ≤ 1.5 times ULN
* Able to take folic acid and vitamin B12
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must agree to use effective contraception
* No active infection or serious concomitant systemic disorder in compatible with the study
* No thrombosis or vascular ischemic events within the last 12 months, including any of the following:
* Deep venous thrombosis
* Pulmonary embolism
* Transient ischemic attack
* Cerebral infarction
* Myocardial infarction
* No peripheral edema ≥ grade 3
* No serious or non-healing wounds
* No second p…
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
Progression-free survival
Timeframe: From registration to clinical evidence of disease progression or death without progression, assessed up to 3 years