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 range18 Years
SexALL
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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.
✓. 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.
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
. 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).