Unique ID issued by UMIN | UMIN000001002 |
---|---|
Receipt number | R000001202 |
Scientific Title | Phase I study using BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer |
Date of disclosure of the study information | 2008/01/30 |
Last modified on | 2011/08/01 08:16:48 |
Phase I study using BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer
Phase I study using BK-UM for patients with recurrent ovarian cancer
Phase I study using BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer
Phase I study using BK-UM for patients with recurrent ovarian cancer
Japan |
Patients with recurrent ovarian cancer
Obstetrics and Gynecology |
Malignancy
NO
Safety
Efficacy
Exploratory
Pragmatic
Phase I
Determination of the recomemded dose after analizing the dose limiting toxicity
1. Evaluation for efficacy of therapy
2. Screening the predictive markers for
efficacy of therapy
3. Pharmacokinetics
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Anticancer agents
20 | years-old | <= |
75 | years-old | > |
Female
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
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
24
1st name | |
Middle name | |
Last name | Shingo Miyamoto |
Fukuoka Univeristy Hospital
Department of Obstetrics and Gynecology
45-1, 7-chome, Nanakuma, Jyounan-ku, Fukuoka city, Fukuoka perfecture
092-801-1011
1st name | |
Middle name | |
Last name | Kenji Yamaguchi |
Fukuoka University Hospital
Clinical research assist center
45-1, 7-chome, Nanakuma, Jyounan-ku, Fukuoka city, Fukuoka perfecture
092-801-1011
kenji0715@adm.fukuoka-u.ac.jp
Fukuoka University Hospital
Japan Science and Technology agency
Japan
NO
2008 | Year | 01 | Month | 30 | Day |
Unpublished
Open public recruiting
2007 | Year | 11 | Month | 26 | Day |
2007 | Year | 12 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 06 | Month | 01 | Day |
2008 | Year | 01 | Month | 30 | Day |
2011 | Year | 08 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001202
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