UMIN-CTR Clinical Trial

Public title

Feasibility reevaluation of 75mg/m2 dose of docetaxel in Japanese patient with previously treated non-small cell lung cancer

Acronym

Feasibility reevaluation of 75mg/m2 dose of docetaxel

Scientific Title

Feasibility reevaluation of 75mg/m2 dose of docetaxel in Japanese patient with previously treated non-small cell lung cancer

Scientific Title:Acronym

Feasibility reevaluation of 75mg/m2 dose of docetaxel

Region

Japan

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To reevaluate satety and tolerability of 75mg/m2 dose of docetaxel.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The frequency of DLT and tolerability.

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

Docetaxel

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

20

years-old

<=

Age-upper limit

74

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven non-small-cell lung cancer.
2) Patient who has measurable lesion by RECIST.
3) Patients who have previously treated one or two regimen including at least one platinum-based regimen.
4) Interval from previous treatment, of following, at enrollment;
(a) Chemotherapy: more than 4 weeks after the last chemotherapy.
(b) Radiation: more than 4 weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs.
5) Aged range from 20 to 74 years.
6) ECOG performance status: 0-1
7) No history of receiving chemotherapy against other concomitant malignancy.
8) Adequate organ functions;
(a) WBC >= 4,000/mm3 and Netrophile >= 2,000/mm3
(b) Hb >= 9.0 g/dL
(c) Plt >= 100,000/mm3
(d) T. Bil <= 1.5 g/dL
(e) AST and ALT, x 2.5 of upper limit of normal or less (f) Serum creatinine <= 1.5 mg/dL
(g) PaO2 >= 70 torr (at room)
9) Written informed consent.

Key exclusion criteria

1) Patient with prior chemotherapy, consisting of docetaxel.
2) Patients with symptomatic brain metastasis.
3) Patients with massive pleural or pericardial effusion.
4) Patients with active concomitant malignancy.
5) Patients with pregnancy or lactation.
6) Patients with other clinically significant complications.
(a) uncontrollable cardiovascular disease.
(b) Active lung disease such as interstitial pneumonia, idiopathic pulmonary fibrosis.
(c) Active severe infections.
(d) History of active psychological disease.
(e) Inappropriate patients for this study judged by the physicians.
7) Patients with steroid treatment.
8) Patients with >= grade 2 of peripheral neuropathy.
9) Patients who had a history of severe drug allergy.

Target sample size

26

Name of lead principal investigator

1st name
Middle name
Last name	Hisamichi Aizawa

Organization

Kurume University School of Medicine

Division name

Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine

Zip code

Address

67 Asahi-machi, Kurume, Fukuoka

TEL

Email

Name of contact person

1st name
Middle name
Last name	Kazuhiko Yamada

Organization

Kurume University School of Medicine

Division name

Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine

Zip code

Address

TEL

Homepage URL

Email

Institute

Division of Respirology, Neurology, and Rheumatology,
Department of Internal Medicine, Kurume University School of Medicine

Institute

Department

Personal name

Organization

Division of Respirology, Neurology, and Rheumatology,
Department of Internal Medicine, Kurume University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

2010

Year

01

Month

13

Day

URL releasing protocol

Publication of results

Published

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

2009

Year

12

Month

28

Day

Date of IRB

Anticipated trial start date

2010

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

01

Month

13

Day

Last modified on

2015

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003663