None listed
Conditions
Interventions
Drug : This study is a phase II, open label single center study. All participating patients must sign on the written informed consent form.
This clinical study is targeted for the patients who progre
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients have any histologically-confirmed inoperable/advanced/metastatic solid tumor (except non-small cell lung cancer) by pathology report and have received, been intolerantTET who progressed after treated with first line cisplatinplatinum containing chemotherapy (not more than two line). to, been ineligible for or refused all treatment known to confer clinical benefit.chemotherapy AND achieved objective response (SD, PR, or CR) Sufficient tumor tissue to perform ALK IHC and ALK FISH is required. Both tests will be performed at Asan Medical Center. Tumor with ALK IHC positive and ALK FISH positive = 1 unidimensionally measurable lesion as defined by RECIST v1.1 After ALK test by Ventana IHC (Appendix 2), patient samples will also be tested by FISH Vysis® ALK Break Apart FISH Probe Kit (Abbott). Age =18 years old Lift expectancy of at least 12 weeks ECOG PS of 0-2 Adequate hematologic function Platelet count = 100 x 109/L ANC =1500 cells/uL Hemoglobin = 9.0 g/dL Adequate renal function: An estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease equation of at least 45 mL/min/1.73 m2 Patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment. Adequate hematologic function Measurable disease (by RECIST v1.1) prior to the administration of study treatment Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline). Asymptomatic CNS lesions might be treated at the discretion of the investigator as per local clinical practice. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment. In all cases, radiation treatment must be completed at least 14 days before enrollment and patients must be clinically stable. For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment. Able and willing to provide written informed consent prior to performing any study-related procedures
Exclusion criteria
Exclusion criteria: ? TET with neuroendocrine feature or small cell histology ? Prior participation in a study investigating pemetrexed or practical treatment with pemetrexed ? Serious cardiac condition, such as myocardial infarction, angina, or heart disease ? Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact in PFS and OS for the current malignancy). ? Liver disease characterized by: – ALT or AST > 3 × ULN (= 5 × ULN for patients with concurrent liver metastasis) confirmed on two consecutive measurements OR – Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices ? National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy such as radiotherapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication ? History of organ transplant ? Pregnant or lactating women ? Known HIV positivity or AIDS-related illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to see objective response rate of pemetrexed after progression from platinum containing chemotherapy in advanced TET. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary purpose is to verify progression free survival (PFS), objective tumor response (ORR) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and toxicity according to NCI CTC version 4.0.;The secondary purpose is to verify overall survival (OS) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoonsook Kang
Asan Medical Center
Outcome results
None listed