Clinical trial: AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma (NCT01105390)

Eligibility criteria:
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 primary malignancy except in situ carcinoma of the cervix or breast, other
             in situ malignancies, adequately treated basal cell carcinoma of the skin, or other
             malignancy within the past 3 years with no evidence of recurrence

          -  No concurrent antiretroviral therapy for HIV-positive patients

          -  At least 4 weeks since prior radiotherapy

          -  More than 30 days since major surgery procedures or > 14 days since any minor surgical
             procedure and recovered

               -  Central venous catheter placement, fine-needle aspiration, thoracentesis, or
                  paracentesis are not considered major or minor surgical procedures

          -  No prior systemic chemotherapy for mesothelioma

          -  No prior intracavity cytotoxic drugs or immunomodulators (unless for the purpose of
             pleurodesis)

          -  No prior anti-HGF monoclonal antibody AMG 102, other c-MET, or HGF inhibitors

          -  No prior or concurrent anticoagulation therapy within the past 7 days

               -  Low-dose Coumadin-type anticoagulants or low-molecular weight heparin for
                  prophylaxis against central venous catheter thrombosis allowed

          -  No investigational agents within the past 4 weeks
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? 1