Continuous administration trial of Bevacizumab for platinum-resistant recurrent ovarian cancer patients
- Conditions
- platinum-resistant recurrent ovarian cancerhistologically confirmed epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer
- Registration Number
- JPRN-jRCTs031180244
- Lead Sponsor
- Shoji Tadahiro
- Brief Summary
The efficacy of BBP(bevacizumab beyond progressive) in platinum-resistant recurrent ovarian cancer using bevacizumab as pretreatment has been proven, and the prognosis is expected to be improved.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 103
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(The value of CA 125 within 2 weeks before treatment >= twice the upper limit of hospital reference value) 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 >= 10.0x10000 /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)
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). However 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival:PFS
- Secondary Outcome Measures
Name Time Method 1. Overall survival: OS <br>2. Objective Response Rate: ORR <br>3. Safety <br>4. Number of paracentesis <br>5. Tumor marker (CA125) response rate