ovarian cancer
Conditions
Interventions
Test group:Apatinib Mesylate Tablets: 500mg, PO.QD, continuous administration
Etoposide Capsules 100mg, PO.Qd, D1-D10, Q3W. The tolerance of Apatinib Mesylate Tablets is evaluated at 14th day after administration, subjects with well tolerance will increase the dose to 750mg, qd
Control group:Etoposide Capsules 100mg, PO.Qd, D1-D10, Q3W. Untill the disease progress.
Sponsors
GuangXi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old, female patients; 2. ECOG PS0-1 score; 3. platinum-resistant relapse ovarian cancer patients, who with measurable lesions; 4. Subjects have already recovered from the injury caused by other treatment (NCI-CTCAE 4.0 classification =1 grade), among which other cytotoxic drugs, radiation and surgical therapy =4 weeks; EGFR TKI molecular targeting agents =2 weeks; 5. Baseline blood routine and biochemical examination criteria: Hemoglobin =90g/L; Absolute neutrophil count (ANC) =1.5×109/L; Blood platelet =80×10^9/L; ALTAST=2.5×ULN =5×ULN (the patients with liver metastasis); Serum total bilirubin =1.5×ULN; Serum creatinine =1.5×ULN or endogenous creatinine clearance rate =45 ml/min (Cockcroft-Gault formula); 6. Without blood or blood product transfusion in 14 days, and without G-CSF or other hematopoietic stimulating factors treatment; 7. Expected lifetime =3 months; 8. Subjects voluntarily join the study, sign informed consent, have good compliance, and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Biochemical relapse ovarian cancer patients; 2. Subjects are confirmed allergic to apatinib, etoposide and/or the ingredients; 3. Subjects with high blood pressure and antihypertensive drug treatment can't go back to normal level (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), I magnitude or more serious coronary heart disease, I magnitude cardiac arrhythmias (including women QTc interphase 470 ms or higher); 4. Subjects, According to NYHA standard, have ? ~ ? cardiac insufficiency, or cardiac color ultrasound revealed left ventricular ejection fraction (LVEF) 1.5, APTT > 1.5 ULN), bleeding tendency; 9. Patients with hereditary or acquired bleeding or thrombosis tendency (haemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism); 10. Long-unhealed wound or fracture; major surgery, serious traumatic injury, fracture or ulcer within 4 weeks; 11. Patients with abdominal fistula, gastrointestinal perforation or intraperitoneal abscess; and who with active HBV or HCV; 12. Patients with active brain metastases, carcinomatous meningitis, spinal cord compression; CT or MRI screening identify brain or pia mater disease (the brain metastasis patients who have finished therapy 21 days before drug administration and symptom is stable can be included, but transcranial MRI, CT or venography should be perform to confirm the patients without cerebral hemorrhage); 13. Radiography (CT or MRI) show the distance between tumor and large blood vessel = 5 mm, or large blood vessel is invaded locally by tumor; 14. Lactating women; 15. History of other malignancy over the past 5 years (except for cured skin basal cell carcinoma and cervical in situ cancer0; 16. Patients who have a history of psychotropic substance abuse and are unable to quit or have a history of mental disorders; 17. Participated in other clinical drug trials 4 weeks before the start of the study; 18. Patients who have received VEGFR inhibitors, such as sorafenib, sunitinib; 19. Patients who have received etoposide treatment; 20. Patients have concomitant disease that can affect patients’ safety or study completion, according to the judgement of investigators; 21. Unsuitable patients judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate;objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Overall Survival;Time to Progression;Quality of life; | — |
Countries
China
Contacts
Public ContactYang Zhijun
GuangXi Medical University Affiliated Tumor Hospital
Outcome results
None listed