UMIN-CTR Clinical Trial

Public title

Efficacy and safety on prophylactic oral steroid and minocycline for rash in patients treated with Erlotinib

Acronym

Efficacy and safety on prophylactic oral steroid and minocycline for rash in patients treated with Erlotinib

Scientific Title

Efficacy and safety on prophylactic oral steroid and minocycline for rash in patients treated with Erlotinib

Scientific Title:Acronym

Efficacy and safety on prophylactic oral steroid and minocycline for rash in patients treated with Erlotinib

Region

Japan

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate efficacy and safety on prophylactic oral steroid and minocycline for rash in patients treated with Erlotinib against pretreated recurrent non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Skin toxicity (Grade2-) rate at week 4

Key secondary outcomes

Time to the onset of skin toxicity (any Grade)
Skin toxicity appearance rate of each Grade
Antitumor effect
Time to Treatment Failure
Overall Survival
Safety
Quality of life
Time to recovery from skin toxicity

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

Erlotinib : 150mg/day p.o.
Predonisolone : 5mg/every other day p.o. on days 1-28
Minocycline : 100mg/day p.o. on days 1-28

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with all of the following conditions;
1) Historogically or cytologically proven stage.IIIb or IV non-small cell lung cancer
2) Recurrent non-small cell lung cancer already treated with 1 or 2 regimen, excluding post-operative adjuvant chemotherapy
3) Age equal or older than 20-y at enrollment
4) No prior treatment with EGFR-TKIs
5) Able to be treated with PO medication
6) PS of 0, 1 or 2
7) Able to be intensely monitored at least for 2 weeks
8) Adequate organ functions, evaluated within 2 weeks before enrollment, as;
a) Netrophile >= 1,500/mm3
b) Hb >= 8.0 g/dL
c) Plt >= 75,000/mm3
d) AST/ALT <= 100 IU/L
e) T. Bil <= 1.5 g/dL
f) SpO2 >= 90%
9) Life expectancy of more than 3 months
10) Interval from previous treatment, of following, at enrollment;
a) Equal or more than 4 weeks after completion of thoracic irradiation
b) Equal or more than 1 week after completion of irradiation except for thoracic irradiation
11) Witten informed consent from the patient

Key exclusion criteria

Patients with at least one of the following conditions are ineligible
1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage
2) Patients unable to be treated with PO drugs
3) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis
4) Pregnancy, breast feeding and suspected pregnancy
5) Active synchronous malignancies
6) Other clinically significant complications
7) History of hypersensitivity for drugs used for this study and tetracyclines antibiotics
Other conditions inadequate for this research

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuo Kawashima

Organization

Toho University Medical Cencer Sakura Hospital

Division name

Department of Internal Medicine

Zip code

Address

564-1 Shimoshizu, Sakura, Chiba

TEL

043-462-8811

Email

Name of contact person

1st name
Middle name
Last name	Tatsuo Kawashima

Organization

Toho University Medical Cencer Sakura Hospital

Division name

Department of Internal Medicine

Zip code

Address

564-1 Shimoshizu, Sakura, Chiba

TEL

043-462-8811

Homepage URL

Email

Institute

Toho University Medical Cencer Sakura Hospital, Department of Internal Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

03

Month

14

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

Enrolling by invitation

Date of protocol fixation

2010

Year

05

Month

07

Day

Date of IRB

Anticipated trial start date

2010

Year

06

Month

01

Day

Last follow-up date

2012

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

03

Month

11

Day

Last modified on

2011

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006199