Patients with recurrent ovarian cancer
Conditions
Interventions
Sponsors
Fukuoka University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Ovarian cancer or primary mesothelial cancer 2. 0 or 1 grade as performance status in ECOG. 3. Treated with taxian and platinum, and then recurrent. 4.Progression of the disease within 6 months after the day of final course in chemotherapy. 5. No effects of previous chemotherapy 6. Peritoneal fluid fulfill the criteria mentioned below; (1)3cm of maximum width using CT scanning. (2)more than 3 ml of peritoneal fluid with more than HB-EGF expression. Or metastatic lesions in abdominal cavity with HB-EGF expression in blood. 7. Less than 0.1 U/ml of anti-diphtheria toxin antibody as a titer within 4 weeks before entry. 8. Fix the port into the abdomen 9. Keep various organs ordinary condition. The data are acceptable within one week before the entry of clinical trial. (1) WBC: > 3000/mmm3 Neutrophil: >1000/mm3 (2) Platelet: >100,000/mm3 (3) Hemoglobin: > 8.0 g/dl (4) AST, ALT: < 2.5 times of normal limit in Fukuoka university hospital (< 5 times in a patient with liver metastasis) (5) Toal bilirubin: < 1.5 mg/dl (6) Serum creatinie: < 1.5 mg/dl (7) No difinite cardiac dysfunction (8) <grade 2 in neurotoxicity. 10. 20 to 75 years old 11. Agree to attending this clinical trial
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 previously had seriuos allergic sensitivity 3. exclude the patients who have pregnancy or nursing or have possiblity to be pregnant 4. exclude the patients who have previoursly had some anti-serum 5. exclude the patients who have serious other malignancy influenced on their survival 6. exclude the patients who have the agent used in other clinical trial within 4 weeks. 7. exclude the patients who are recognized as inadequate patients by doctors wth resposibility in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the recomemded dose after analizing the dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation for efficacy of therapy 2. Screening the predictive markers for efficacy of therapy 3. Pharmacokinetics | — |
Countries
Japan
Contacts
Public ContactKenji Yamaguchi
Fukuoka University Hospital Clinical research assist center
Outcome results
None listed