Patients with recurrent ovarian cancer
Conditions
Interventions
Sponsors
Fukuoka University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients who have been already treated with BK-UM and have had no serious adverse effects in clinical trial using BK-UM (Phase I study). 2. Patients who have 0 or 1 grade as performance status in ECOG. 3. Patients who have enough restoring poteintial to keep various organs ordinary coodition. The data are acceptable within one week before the entry of clinical trial. (1) WBC: more than 3000/mmm3 Neutrophil: more than 1000/mm3 (2) Platelet: more than 100,000/mm3 (3) Hemoglobin: more than 8.0 g/dl (4) AST, ALT: more than 2.5 times of normal limit in Fukuoka university hospital (less than 5 times in a patient with liver metastasis) (5) Toal bilirubin: less than 1.5 mg/dl (6) Serum creatinie: less than 1.5 mg/dl (7) No difinite cardiac dysfunction No abnormal finding in ECG: abnormal findings as follows: elevation of ST, abnormalities in T wave, low voltage in QRS, elogantion og QT, arrythmia(ventricular tachcardia, severe bradycardia, atrial-vetricular block) (8) Patients who do not have morethan grade 3 in neurotoxicity. 4. Patients who agree to attending this clinical trial by theri own free will.
Exclusion criteria
Exclusion criteria: 1. exclude the patients who have serious illness or suspect to have serious illness menthioned below (1)exclude the patients who have ischemic heart diseases ro arrythmia to give medical treatment (2)exclude the patients who have less than 50% in ejection fraction using echocardiogram (3)exclude the patients who have cardiac dysfunction as grade III or IV of NYHA or have cardiac infarction within 6 months (4)exclude the patients who have liver schirosis beyond medical control (5)exclude the patients who need the oxigen supplement because of pulmonary intestitial pneumonitis or fiibrosis (6) exclude the patients who need or do medical treatment for mental diseases (7) exclude the patients who have serious diabetes beyond medical control (8) exclude the patients who have ileus or subileus (9)exclude the patients who have serious infection beyond medical control 2. exclude the patients who have progression of disease in clinical trial using BK-UM (Phase I study). 3. exclude the patients who have pregnancy or nursing or have possiblity to be pregnant 4. exclude the patients who are recognized as inadequate patients by doctors wth resposibility in this clinical trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation for efficacy of therapy 2. Screening the predictive markers for efficacy of therapy | — |
Primary
| Measure | Time frame |
|---|---|
| Investigation of safety in continual administration of BK-UM in the same patient with recurrent ovarian cancer | — |
Countries
Japan
Contacts
Public ContactKenji Yamaguchi
Fukuoka University Hospital Clinical research assist center
Outcome results
None listed