UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000177 |
|---|---|
| Receipt number | R000000241 |
| Scientific Title | PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2018/10/03 13:59:55 |
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Basic information
Public title
PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer
Acronym
Amrubicin for Previously Treated Small Cell Lung Cancer
Scientific Title
PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer
Scientific Title:Acronym
Amrubicin for Previously Treated Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
For patients with recurrent or relapsed small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose (RD) of amrubicin for patients with recurrent or relapsed small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Feasibility (estimation of MTD,DLT and RD)
Key secondary outcomes
Effectiveness (anti-tumor effect of amrubicin with recommended dose)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Amurubicin is administered intravenously from day 1 to 3. The treatment is repeated every 3 weeks. G-CSF was routinely given once a day from day 8. The administration of G-CSF continues up to 7 days before the next chemotherapy. Starting dose (step 1) of amurubicin is 35mg/m2.Step 2 is 40mg/m2 and step 3 is 45mg/m2.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed small cell lung cancer.
2.Previous treatment with two regimens is allowed. Prior regimen should include one drug among platinum, VP-16, CPT-11 and topotecan.
3.At least 28 days interval from the last administration of previous chemotherapy.
4.At least 28 days interval from the last delivery of irradiation to any organs (except thorax and pelvis) for palliation.
5.Life-expectancy is more than 2 months.
6.PS 0-1(ECOG).
7.Patients who have measurable lesions with RECIST criteria.
8.Adequate organ functions (bone marrow, liver, heart, lung, kidney etc.). Patients are required to satisfy all of the next-mentioned criteria:
1.Hematological: WBC > 4000/mm3 and < 12000/mm3, Granulocyte count > 2000/mm3, Platelet count > 12000/mm3, Hb > 9.5 g/dl
2.Hepatic: AST & ALT < * 2.5 upper normal limit, Total bilirubin < 1.5mg/dl
3.Renal: Serum creatinine < upper normal limit
4.Pulmonary: PaO2 > 60 Torr , %VC >50% , %FEV1.0 > 60%
5.Cardiac: Ejection fraction > 60% is needed (estimated by echocardiography)
9.Age 20 to 74 years.
10.Written informed consent prior to the enrollment of the study.
Key exclusion criteria
Patients are excluded from the study if they belong to any of the following categories.
1.Serious medical co-morbidities.
1)Interstitial pneumonia or pulmonary fibrosis is recognized by plain chest X-ray film.
2)Active infectious diseases.
3)Pleural effusion, ascites or pericardial effusion requiring tube drainage.
4)Uncontrolled diabetics.
5)diarrhea (watery),intestinal.paralysis or obstructive bowel diseases.
6)Any comorbidities which seem to severely interrupt the planed treatment.
2.A symptomatic brain metastasis.
3.Patients with an impaired heart function.
4.Pregnant or lactating women. Patients who have a possibility of pregnancy.
5.Severe hypersensitivity for any drug in the past.
6.Previous radiotherapy to more than two sites.
* Prophylactic cranial irradiation is not included.
* Whole brain irradiation for apparent brain metastasis is considered as one prior radiotherapy.
* In case of previous radiation to vertebra and/or shaft bone, up to 2 sites are permitted (i.e. Th3 + Th4, Th3 + femur, femur + humerus).
* In case of previous radiation to pelvis or thorax, history of radiotherapy to any other site is not permitted.
7.A case judged to be unsuitable for enrollment of the study.
8.Previous administration of anthracyclin or its analogues.
9.Patients who are suffered from active double cancer.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katakami |
Organization
Kobe City General Hospital
Division name
Division of Pulmonary Medicine
Zip code
Address
4-6 Minatojima-Minamimachi Chuo-ku
TEL
078-302-4321
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Hayashi |
Organization
Kobe City General Hospital
Division name
Division of Pulmonary Medicine
Zip code
Address
4-6 Minatojima-Minamimachi Chuo-ku
TEL
078-302-4321
Homepage URL
katakami@kcgh.gr.jp
Sponsor or person
Institute
Kobe City General Hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute of Biomedical Research and Innovation
Kobe City West Hospital
Nishikobe Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000241
