Endometrial Cancer Recurrent Clinical Trial
Official title:
Phase II Trial of Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer
The majority of endometrial cancer patients with disease spread beyond the uterus will progress within 1 year. Platinum-based chemotherapy was used as the first-line treatment in metastatic or advanced endometrial cancer. There is no standard protocol for the second-line option when tumors persist or recur. In vitro and in vivo studies showed Crizotinib, an approved drug for the treatment of ALK-positive non-small cell lung cancer, demonstrated activities in endometrial cancer with c-MET kinase and Sema domain mutations. As a consequence, a phase 2 clinical trial to investigate the efficacy of Crizotinib in endometrial cancer patients with MET mutation is initiated.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age no less than 20 years and no more than 75 years, at the time of acquisition of informed consent. - Histological confirmed epithelial endometrial cancer - Disease recurrent after curative therapy or adjuvant therapy including surgery, chemotherapy, radiotherapy or hormone therapy - Metastatic/recurrent/persistent endometrial cancer - Tumor tissue with high expression in immunohistochemistry stain (IHC) or somatic c-MET mutation - Patients with symptomatic recurrent lesion or Image diagnosis (including ultrasound, Computed Tomography or Magnetic Resonance Imaging) recurrent status - ECOG Performance status 0-2 - At least one distinct tumor, not previous irradiated, measurable lesion according to RECIST (version 1.1) - Adequate organ function Bone marrow: Absolute neutrophil count (ANC) = 1.5 x 10^9/L WBC = 3.0 x 10^9/L Platelet count = 100 x 10^9/L Hemoglobin = 9 g/dL Hepatic: Total bilirubin level = 1.0 x UNL AST and ALT = 3.0 x UNL Renal: Creatinine level = 1.5 mg/dL in men, =1.4 mg/dL in women; or Estimated CCr = 60 mL/min (CCr is estimated by Cockcroft-Gault formula) - Negative pregnancy test for women of childbearing potential only - Patient willing to provide blood sample for research purposes - Written informed consent Exclusion Criteria: - Presence or history of malignancy disease other than endometrial cancer that has been diagnosed with past five years - Other anti-tumor agent such as systemic chemotherapy, hormone therapy or surgery within 2 weeks before the commencement of study treatment or radiotherapy within 4 weeks before the commencement of study - Active uncontrolled infection - Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (<6 months before enrollment) - Poor compliance - Pregnant or breastfeeding women, where pregnancy is confirmed by a positive hCG laboratory test. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng Kung University Hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital | Chi Mei Medical Hospital, Kaohsiung Medical University, Kaohsiung Veterans General Hospital. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in best overall response rate | CT scan or MRI will be used to evaluate the response every 2 cycles according to the RECIST 1.1 criteria. The best overall response rate is the proportion of patients in whom a complete response (CR) or partial response (PR) was observed. | CT scan or MRI will be done at baseline and at the end of every 2 cycles (each cycle is 28 days) until the date of first documented progression or date of death from any cause, whichever came first, up to 104 weeks | |
Secondary | Progression-free survival | CT scan or MRI will be used to evaluate the response according to RECIST 1.1 criteria. Progression-free survival is defined as the time from the time of treatment to disease progression or death from any cause. | CT scan or MRI will be done at baseline and at the end of every 2 cycles (each cycle is 28 days) until the date of first documented progression or date of death from any cause, whichever came first, up to 104 weeks | |
Secondary | Overall survival | Overall survival is defined as defined as the time from the start of treatment to death from any cause. | Overall survival will be followed from the start of treatment to death from any cause, up to 104 weeks |
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