first recurrent or refractory of ovarian clear cell carcinoma
Conditions
Interventions
Gemcitabine 1000mg per m2 day1,15 Cisplatin 40mg per m2 day1,15 q4w 6cycles maximum 10 cycles Bevacizumab 15 mg per kg day1 q3w 8cycles maximum 13 cycles
Sponsors
Kansai clinical oncology group(KCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed ovarian clear cell carcinoma,included mixed type,recurrence or refractory after or during first treatment 2)First treatment-operation only,chemotherapy only,operation with chemotherapy 3)There is no limitation of interval of recurrence-Pt sensitive,Pt resistant and refractory are eligible 4)No use of gemcitabine for first treatment 5)Measurable disease 6)Age 20 to 75 years old 7)PS 0 to 2 8)Labo data within two weeks prior to entry satisfy following criteria 1.neutro>=1500mm3 2.platelet>=10*104/mm3 3.Hb>=9.0/dl transfusion available 4.T-Bil<=1.5mg/dl 5.AST and ALT<=100IU/l 6.serum creatinine<=1.5mg/dl 7.eGFR>=50ml/min/1.73m2 8.PT-INR<=1.5 If patient takes warfarin,1.5<=PT-INR<=2.5 9.Urine protein<=1+ If urine protein=2+, confirm urine protein <=1.0g/day in urine collection 9)Patient who is expected to be alive more than 90 days 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patient is contraincicated for use in gemcitabine,cisplatin and bevacizumab 2)Patient with uncontrolled heart disease,renal disease and diabetes mellitus 3)Patient with interstitial pneumonia or lung fibrosis 4)Patient with paresis of intestine or ileus 5)Patient with active infection 6)Patient who had chest and abdominal radiation therapy prior to registration 7)Patient with active other malignancy,excluded carcinoma in situ 8)Patient with history of severe drug allergy 9)Patient with obstructive bowel disease,diverticular perforation,intestinal fistula,perforation of the digestive tract,intraperitoneal abscess and Patient with intestinal invasion or ileus confirmed by pelvic examination or CT 10)Patient who have central nerve metastasis with symptom 11)Patient with pregnancy or breast-feeding,Patient who has possibility of pregnancy,notwilling to contraception 12)the following patient 1.Patient with arterial thrombosis or venous thrombosis,included cerebrovascular disorder,stroke,transient ischemic attack or subarachnoid bleeding within 6 months prior to this treatment,but history of arterial thrombosis or venous thrombosis,if control is good,registration is possible. 2.Patient who meets definition of NYHA 2 or has history of myocardial infarction,unstable angina or congestive heart failure 3.Patient with sever arrhythmia who needed medication,excluded atrial fibrillation or paroxysmal supraventricular tachycardia 4.Patient with uncontrolled hypertension(BPs>=150mmHg or BPd>=100mmHg irrespective of treatment) 5.Unhealed wound,ulcer and fracture 6.Patient with positive HBs antigen,HBc antibody or HBs antibody and HPV-DNA>=2.1 log copies/ml 7.HIV infection 13)Patient who received other test drug within 30 days prior to this treatment 14)Attending physician decides to entry inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival,Overall survival,Disease control rate,Adverse events,Relationship between pathological findings and response | — |
Countries
Japan
Contacts
Public ContactKimihiko Ito
Kansai Rosai Hospital Obstetrics and gynecology
Outcome results
None listed