UMIN-CTR Clinical Trial

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

small-cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

koichi-t@kokyu.med.kyushu-u.ac.jp

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

05

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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