A single-arm, phase II study of axitinib and chemotherapy in patients with recurred or metastatic salivary gland cancer
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 66
1. Histologically confirmed salivary gland cancer
(adenoid cystic carcinoma, mucoepidermoid carcinoma, mammary analog secretory carcinoma, acinic cell carcinoma, adenocarcinoma NOS, salivary ductal carcinoma carcinoma))
2. Locally advanced or metastatic local disease with evidence of disease progression when comparing imaging findings (CT, MRI, X-ray) taken within the last 9 months with imaging findings just before registration. (Progress should be documented in accordance with RECIST 1.1 criteria.)
3. Those with a disease that cannot be expected to be cured by surgery, radiation, or combination therapy for therapeutic purposes, and those who are above the 1st line
4. Presence of at least one measurable target lesion based on RECIST 1.1
5. Age 19 or older
6. ECOG performance status 0, 1
7. Subjects previously treated with chemotherapy or topical therapy are permitted if their toxicity resolved to grade 1 or lower at trial enrollment and the last treatment was performed at least 4 weeks prior to baseline evaluation.
8. Proper organ function
• Absolute neutrophil count (ANC) = 1500/µL
• Platelets =100,000/µL
• Hemoglobin (Hb) = 9.0 g/dL
• Serum creatinine = 1.5 times the upper limit of normal (ULN)
• Serum bilirubin = 1.5 times the upper limit of normal (ULN)
• AST, ALT = 3.0 times upper limit of normal (ULN) (with or without liver metastasis)
9. Subjects who are willing and able to comply with the trial protocol during the trial period
10. Subjects who sign a written informed consent prior to participation in the study and understand that they have the right to withdraw their consent from participation in the study at any time without penalty
1. Subjects without measurable lesions
2. Subjects who underwent chemotherapy, radiation therapy, or surgery within 4 weeks prior to study enrollment, except palliative radiation therapy for non-target lesions (administered within 2 weeks prior to study enrollment)
3. Subjects with intestinal obstruction or urge obstruction, recent active upper gastrointestinal bleeding
4. Pregnant or lactating women
5. Subjects of childbearing potential who did not have a pregnancy test or have a positive result at baseline. (Post-menopausal women with amenorrhoea longer than 12 months are considered fertile.)
6. Men or women of childbearing age who are unwilling to use contraceptive methods during the trial
7. Subjects with a history of other malignant diseases within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ
8. Subjects with a history of uncontrolled seizures, central nervous system disorders, or psychiatric disorders judged to be clinically significant by the investigator, which could interfere with the understanding of written informed consent or affect compliance with the study drug
9. Subjects who have experienced clinically significant heart disease (e.g., congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias, etc.) or myocardial infarction within the past 12 months
10. Subjects who have undergone organ transplant requiring immunosuppressive therapy
11. Subjects with severe hypersensitivity to the active ingredient or excipient of Axitinib
12. Hypertension that is not controlled by medication (>160/100mmHg)
13. Those with a history of deep vein thrombosis or pulmonary embolism within the past 6 months
14. Those with a history of severe pulmonary hemorrhage or hemoptysis within the past 6 months
15. Those with a history of uncontrolled coagulation disorder
16. Those who have a history of treatment with angiogenesis inhibitors before
17. Those who must take strong CYP3A4 derivatives (carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, amobarbital, phenytoin, primidone, rifabutin, rifampin, nevirapine, St John’s wort)
18. Symptomatic brain and spinal cord metastases
19. Uncontrolled pleural fluid, pericardial fluid, or ascites
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6months Progression-free survival(PFS) rate)
- Secondary Outcome Measures
Name Time Method Toxicity;response rate;overall survival, OS;duration of response;Progression-free survival