UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005606 |
|---|---|
| Receipt number | R000006432 |
| Scientific Title | PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy |
| Date of disclosure of the study information | 2011/05/16 |
| Last modified on | 2012/05/17 11:29:29 |
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Basic information
Public title
PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy
Acronym
PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy
Scientific Title
PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy
Scientific Title:Acronym
PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy
Region
| Japan |
Condition
Condition
small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy, phase I aims to characterize the dose limiting toxicity (DLT) of amrubicin hydrochloride, estimate the maximum tolerated dose (MTD) based on the number of patients with the DLT, and determine the recommended dose (RD) for phase II.
Phase II aims to evaluate the efficacy and safety of amrubicin hydrochloride monotherapy at the RD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase 1: Estimation of the DLT and MTD, determination of the RD, assessment of adverse events.
severity of adverse events is assessed according to the "Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0."Phase 2: Response rate (CR + PR)
Tumor response is assessed according to the "Response Evaluation Criteria in Solid Tumors (the RECIST criteria)."
Key secondary outcomes
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
Amrubicin hydrochloride is intravenously administered for 3 consecutive days every 3 weeks. Three weeks comprise one course of treatment, and subjects receive 2 or more courses but a maximum of 4 courses.
In phase I, the starting dose is 30 mg/m2/day, followed by stepwise dose level increase up to the MTD.
In phase II, the recommended dose determined in phase I, 35 mg/m2, is used.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1)Histological or cytological diagnosis of lung cancer
(2)Clinical stage IIIB (not indicated for radical radiotherapy) or IV
(3)Previously treated with one regimen of chemotherapy for small-cell lung cancer (including intrathoracic administration of an anticancer drug)
(4)At least 28 days have passed since the final dose of the prior chemotherapy(5)Have not undergone surgery or thoracic radiotherapy within 28 days prior to enrollment (i.e., 28 days counting from the day of final irradiation as day 0)
(6)Have measurable lesions according to the RECIST criteria (minimally 20 mm measured by CT scan with 10-mm slice thickness, or 10 mm by CT scan with 5-mm slice thickness; lesions in an irradiated area are not considered measurable)
(7)Age 70 years or older (at consent)
(8)ECOG Performance Status (PS) 0 or 1
(9)Have adequate function of major organs (bone marrow, liver, kidneys, lungs, and heart) defined as follows:White blood cells>=4,000/mm3 or
<=12,000/mm3
Neutrophils>=2,000 /mm3
Platelets>=100,000 /mm3
Hemoglobin>=10 g/dL
AST and ALT<=2.5 times ULN for the medical institution
Serum total bilirubin<=1.5 mg/dL
Serum creatinine<=1.5 times ULN for the medical institution
PaO2>=65mmHg
LVEF (echocardiography)>=60%
ECG: No abnormal findings requiring treatment
(10)Provided written consent in person for participation in this study
Key exclusion criteria
(1)Previously treated with amrubicin hydrochloride
(2)Interstitial pneumonia or pulmonary fibrosis suspected on chest CT
(3)Abnormal cardiac function, myocardial infarction, or history thereof
(4)Received the maximum allowed cumulative dose* of cardiotoxic drugs such as anthracycline derivatives in prior therapy
*Maximum allowed cumulative doses are 25 mg/kg (body weight) for daunorubicin hydrochloride, 500 mg/m2 (body surface area) for doxorubicin hydrochloride, 900 mg/m2 for epirubicin hydrochloride, and 950 mg/m2 for pirarubicin hydrochloride
(5)Symptomatic brain metastases
(6)Pleural effusion, ascites, or pericardial effusion requiring drainage(7)Serious complications (cancerous pericarditis, superior vena cava syndrome, serious infection)
(8)History of drug allergy judged unacceptable for participation in the study
(9)Pregnant, possibly pregnant, or desire to become pregnant
(10)For other reasons judged by the investigator (principal investigator or subinvestigator) to be inappropriate for this study
(11)Active multiple cancers treated within the past 5 years as of the day of enrollment or during treatment with amrubicin hydrochloride
(12)Uncontrolled diabetes mellitus, chronic steroid use
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Nakanishi |
Organization
Kyushu University, Graduate School of Medical Sciences
Division name
Research Institute for Diseases of the Chest
Zip code
Address
3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL
092-642-5378
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Takayama |
Organization
Kyushu University, Graduate School of Medical Sciences
Division name
Research Institute for Diseases of the Chest
Zip code
Address
3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL
092-642-5378
Homepage URL
koichi-t@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
| 2011 | Year | 05 | Month | 16 | 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 | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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
| 2011 | Year | 05 | Month | 16 | Day |
Last modified on
| 2012 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006432
