Patients with advanced or recurrent ovarian cancer (include fallopian tube cancer and peritoneal cancer)
Conditions
Interventions
BK-UM+gemcitabine
Gemcitabine
Sponsors
Osaka University
The research foundation for Microbial Diseases of Osaka University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients who are histologically proved ovarian cancer, fallopian tube cancer or peritoneal cancer. 2)ECOG performance status: 0-2 grade. 3)Patients who are platinum-containing drug resistant. 4)Patients with a history of the taxanes (paclitaxel or docetaxel) use. 5)The patient who satisfy any or all of the following items. 1.Patients who have measurable lesions meeting RECIST guideline. 2.Patients who have immeasurable lesions by diagnostic imaging and who have CA125 > 70. 6)Patients who do not have a history of gemcitabine use. 7)Patients who passed in the period when the current chemotherapy does not have any effects. 8)Patients who have ascites or intra-abdominal dissemination/metastasis. 9)Patient who can place a port into the abdominal cavity. 10)Patients who have the acceptable data within 2 weeks before the entry of the clinical trial. 1.WBC: > 3,000/microl Neutrophil > 1,000/microl 2.Platelet: > 100,000/microl 3.Hemoglobin: > 8.0 g/dl 4.AST, ALT: < 100 U/l (IU/l) 5.Total biirubin: < 1.5 mg/dl 6.Serum creatinine: < 1.5 mg/dl 7.No definite cardiac dysfunction: abnormal findings as follows: ST segment elevation, T-wave abnormality, low voltage in QRS, long QT syndrome, arrhythmia (ventricular tachycardia, severe bradycardia, atrioventricular block). 8.Patient without the neuropathy more than grade3. 11)Age: 20 years old or older, and under 75 years old. 12)Patients who agree to attend this clinical trial by their own will.
Exclusion criteria
Exclusion criteria: 1)Patient who have metastasis except for abdominal cavity or have the liver metastasis. 2)Patients who have serious illness or suspect to have serious illness mentioned below. 1.Patients with coronary heart disease or arrhythmia to need treatment. 2.Patient with left ventricle ejection fraction less than 50% in echocardiogram. 3.Patients who have cardiac dysfunction as grade III or IV of NYHA or have cardiac infarction within 6 months. 4. patient with pulmonary embolism. 5.Patients with decompensated cirrhosis. 6.Patients with interstitial pneumonia or pulmonary fibrosis, that is confirmed by chest X-ray and is associated with clinical symptoms. 7.The patients who need psychotic therapy or who take psychiatric medication. 8.Patients with poorly-controlled diabetes. 9.Patients with ileus or subileus. 10.Patients with active or poorly-controlled serious infection. 11.Patients with myelosuppression. 3)Patients with serious drug hypersensitivity. 4)Pregnant women, nursing mothers, or patients with chance of pregnancy. 5)Patients with a history of antiserum use. 6)Patient with multiple malignancies or with those history 5 years before agreement. 7)The patient who have a history of deferred treatment more than 6 weeks by hematotoxicity caused by the taxanes or the platinums use. 8)Patients who received the investigational drug 4 weeks before agreement. 9)Patients with a history of BK-UM use. 10)Patients undergoing radiation therapy to chest. 11)The patient that principal investigator or sub investigators judged the participation in this clinical trial to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) observation of curative effect 2) Exploration of biomarker predicting curative effect 3) Plasma CRM197 concentration, plasma gemcitabine concentration (confirmation of the accumulation) | — |
Countries
Japan
Outcome results
None listed