platinum-resistant recurrent ovarian cancer
Conditions
Interventions
chemotherapy + Bevacizumab
chemotherapy alone
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Patients histologocally confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. 2.Patients must have platinum-resistant disease (defined as progression within <6 months from completion of a minimum of 3 platinum therapy (including Bevacizumab) cycles. (Assessment for disease progression by tumor marker alone is not accepted.) 3.Patients >= 20 years of age. 4.ECOG Performance Status: 0-2 5.Patients can be included if they have a RECIST progression, with either measurable or non-measurable disease. Patient who can be evaluated based on GCIG CA125 criteria is allowed 6.Life expectancy of >= 90 days. 7.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements. 8.Adequate following organ function. a.Neutrophils count >= 1,500 /mm3 b.Platelet count >= 10.0x104 /mm3 c.Hemoglobin >= 9.0 g/dL (Transfusion to maintain >= 9.0 g/dl acceptable) d.Total bilirubin =< 1.2 mg/dL e.AST, ALT =< 100 IU/L (For patients with liver meatstasis, =< 200 IU/L) f.Serum creatine =< 1.5 mg/dL g.Proteinuria =< 1+ (>= 2 +:Confirm that =< 1.0 g in 24 hour urine collection or =< 1.0 the protein / creatinine ratio (UPC ratio) of occasional urine.) h.PT-INR max. =< 1.5 (However, while taking warfarin 1.5 =< PT-INR =< 2.5)
Exclusion criteria
Exclusion criteria: 1.Patient with ovarian borderline malignant tumor.2.History of other clinically active malignancy within 5 years of enrollment,3.Previous treatment with >= 4 anticancer regimens.4.History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.5.Surgery within 28 days prior to the start of study, or anticipation of the need for major surgery during study treatment.6.Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day) or clopidogreln (of more than 75 mg/day).prophylactic use of anticoagulations is allowed.7.Palliative radiotherapy < 14 days prior to anticipate in this study.8.LVEF defined by MUGA/ECHO below 50% (only applicable for patients intended to be treated with pegylated liposomal doxorubicin).9.Pre-existing peripheral neuropathy >=CTC grade 2 for those patients planned to receive paclitaxel.10.Symptomatic CNS metastasis.11.Pregnant or lactating females. or Women of childbearing potential not using highly-effective contraception.12.Patient having the following conditions: a.History or evidence of thrombotic or hemorrhagic disorders. b.New York Heart Association (NYHA) grade II or greater congestive heart failure(CHF) c.serious cardiac arrhythmia requiring medication d.Uncontrolled hypertension e.Non-healing wound, ulcer or bone fracture. f.HBsAg(+), HBcAb and/or HBsAb(+)and >=2.1 log copies/ml of HBV-DNA levels, or HIV(+).13.Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study.14.Known hypersensitivity to any of the study drugs or excipients.15.Patient who is judged inappropriate to participate in this study by the principle investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival:PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival: OS Objective Response Rate: ORR Safety Number of paracentesis Tumor marker (CA125) response rate" | — |
Countries
Japan
Contacts
Public ContactTadahiro Shoji
Iwate Medical University Hospital Obstetrics and Gynecology
Outcome results
None listed