epithelial ovarian cancer
Conditions
Interventions
Case series:Apatinib (250mg, Bid) combined with VP-16 (50mg Qd) oral treatment
Sponsors
Hu'nan Previncial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) female subjects aged 18 to 70 years; 2) Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, cancer of the fallopian tube, or peritoneal cancer; 3) Definition of relapse: demonstration of measurable tumor according to RECIST criteria by an imaging procedure +/- CA-125 > twice of the upper laboratory normal value; 4) Patients must have failed at least 2 available standard chemotherapy regimens +/- secondary cytoreductive surgery when relapse; 5) Adequate hematologic, coagulation, hepatic, renal, and cardiac function, with an Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 6) Adequate contraception; 7) Able to swallow and retain oral medication; 8) A life expectancy of at least 12 weeks.
Exclusion criteria
Exclusion criteria: 1) Diagnosis of any second malignancy within the last 5 years except basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri; 2) History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis; 3) Clinically significant gastrointestinal abnormalities which might interfere with oral dosing; 4) History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment; 5) History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA), history of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; 6) Macroscopic hematuria; 7) Evidence of active bleeding or bleeding diathesis; 8) Uncontrolled hypertension; 9) Urine protein=++ and confirmed >1.0g by the 24h quantity; 10) Pregnancy or lactation period; 11) Allergy to any ingredients of apatinib or VP-16; 12) Whole blood transfusion was received within 120 days before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Disease control rate;Adverse events; | — |
Countries
China
Contacts
Public ContactJie Tang
Hu'nan Previncial Cancer Hospital
Outcome results
None listed