Unique ID issued by UMIN | UMIN000001101 |
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Receipt number | R000001302 |
Scientific Title | Phase I study of weekly amrubicin in patients with refractory or relapsed lung cancer |
Date of disclosure of the study information | 2008/04/20 |
Last modified on | 2008/12/17 15:40:48 |
Phase I study of weekly amrubicin in patients with refractory or relapsed lung cancer
Phase I study of weekly amrubicin for lung cancer patients
Phase I study of weekly amrubicin in patients with refractory or relapsed lung cancer
Phase I study of weekly amrubicin for lung cancer patients
Japan |
lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
The purpose of this study was to evaluate the safety and tolerability, to determine the recommended weekly amrubicin dose, and to conduct a pharmacokinetic study in patients with chemotherpy-refractory or recurrent lung cancer.
Others
response rate
Exploratory
Explanatory
Phase I
Evaluation of safety
Pharmacokinetic study at the first cycle
Response rate in assessable patients
Interventional
Single arm
Non-randomized
Open -no one is blinded
Dose comparison
1
Treatment
Medicine |
Weekly (repetition of dose on 1st/8th day with 15th day rest) administration of amrubicin hydrochloride
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Histologically or cytologically proven lung cancer
2. Refractory to first- or second-line chemotherapy patients or relapsed patients
3. Age over 19, and less than 80
4. Performance Status (ECOG): 0 to 2
5. Adequate main organ functions
WBC>=4000/uL
Neutro>=2000/uL
Hgb>=9.0 g/dL
Platelets>=100000/uL
AST, ALT: less than two times the upper normal limit
T. Bil <=1.5 mg/dL
s-Cr: less than upper normal limit
SpO2 >= 90%
Left ventricular ejection fraction >=60%
6. Postoperative recurrence and asymptomatic brain metastasis
7. Written informed consent
1. Contraindication for amrubicin
2. Carcinomatous pleuritis, pericarditis, pritonitis with local therapy indication
3. Patient can not enroll during radiotherapy, but can be registered after interval (chest: four weeks; without chest: one weeks).
4. Serious medical complication: Uncontrolled angina pectoris, myocardial infarction for less than 3 months; patient with cardiac failure. Uncontrolled diabetes mellitus, hypertension.
5. Infected patients
6. Other clinical difficulties in this study
18
1st name | |
Middle name | |
Last name | Chiyoe Kitagawa |
National Hospital Organization Nagoya Medical Center
Department of Respiratory Medicine
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
052-951-1111
1st name | |
Middle name | |
Last name | Chiyoe Kitagawa |
National Hospital Organization Nagoya Medical Center
Department of Respiratory Medicine
Central Japan Lung Study Group
Central Japan Lung Study Group
Non profit foundation
NO
2008 | Year | 04 | Month | 20 | Day |
Unpublished
The maximum tolerated dose (MTD) was 65 mg/m2.The recommended dose (RD) was determined 60 mg/m2.
Dose limiting toxicity was neutropenia and serum transaminase elevation.
Completed
2006 | Year | 02 | Month | 20 | Day |
2006 | Year | 04 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2008 | Year | 03 | Month | 27 | Day |
2008 | Year | 12 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001302
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