Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma (NCT00402766) | Clinical Trial Compass
CompletedPhase 1
Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma
United States19 participantsStarted 2006-08
Plain-language summary
Primary Objective:
* To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma.
Secondary Objectives:
* To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor tissue by:
* histologic analysis of biopsy tissue
* by non-invasive assessments of tumor vascularity performed before, during and after treatment
* electron microscopy analysis of endothelial cell architecture after patient treatment with imatinib mesylate
* To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate markers in serum.
* To assess the rate of response to therapy.
* To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor (PDGF-R) on malignant mesothelioma tumor cells.
* To determine the pharmacokinetic interaction between agents in this combination regimen.
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
. A written, voluntary informed consent form must be completed prior to beginning any study procedure.
. Patients \>/= 18 years of age.
. Histologically documented diagnosis of malignant mesothelioma.
. Performance status 0-2 (ECOG)
. Patients must have adequate hepatic,renal,\& bone marrow function,defined as the following:(1) total bilirubin \</=1.5xULN;(2) serum glutamate oxaloacetate transaminase (SGOT) \& serum glutamate pyruvate transaminase (SGPT)\</=2.5xULN;(3)creatinine \</= 1.5xULN;(4) ANC \>/= 1.5x10\^9/L;(5) platelets\>/=100 x 10\^9/L.Note:Renal function is only based on serum creatinine level \</= 1.5xULN.The standard Cockcroft \& Gault formula or the measured glomerular filtration rate (GFR) using the appropriate radio labelled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate cranial cruciate ligament (CrCl) for enrollment or dosing.The same method used @ baseline should be used throughout the study.CrCl should be \>/= 45mg/dl.
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
Maximum Tolerated Dose (MTD) of Cisplatin, Pemetrexed, and Imatinib Mesylate Given to Participants with Unresectable or Metastatic Malignant Mesothelioma
Timeframe: After six cycles of 28 day cycles, up 6 months
. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
. Patients who have not received prior chemotherapy for their metastatic or recurrent unresectable malignant mesothelioma; with the exception of patients who have recurrent mesothelioma after induction chemotherapy followed by definitive treatment (surgery +/- radiotherapy). Patients must have had 2 or fewer cycles/doses of induction chemotherapy and must have had tumor response to the induction therapy.
. Patients must have documented unresectable malignant mesothelioma (pleural or peritoneal).
Exclusion criteria
. Patient has received any other investigational agents within 28 days of first day of study drug dosing.
. Patient is \</= 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer, squamous skin cancer, or a cervical carcinoma in situ.
. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure)
. Patients with myocardial infarction within 6 months of study.
. Female patients who are pregnant or breast-feeding.
. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
. Patient has a known untreated or unstable brain metastasis.
. Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).