UMIN-CTR Clinical Trial

Public title

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Acronym

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Scientific Title

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Scientific Title:Acronym

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Region

Japan

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Objective of the study is to investigate efficacy and safety of Erlotinib for previously treated non-small cell lung cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

rseponse rate

Key secondary outcomes

disease control rate, progression free survival, overall survival, evaluation of safety

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 single chemotherapy

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

1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer.
2) Patients who have previously treated with one or two chemotherapy.
3) No prior treatment with epidermal growth factor tyrosine kinase inhibitor.
4) Patients who has at least one or more measurable lesion(s) by RECIST.
5) Performance status (ECOG) 0-2
6) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management.
7) Patients aged 20 years or older.
8) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 3,000/mm3 or over -12,000/mm or less.
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
AST and ALT, x 2 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
SpO2 90% or above.
9) Patients who are considered to survive for more than 3 months.
10) interval:
(1) chemotherapy, more than 3 weeks after the last chemotherapy.
(2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs.
(3) Operation, more than 3 weeks after the last operation (including pleurodesis)
11) Patients providing written informed consent

Key exclusion criteria

1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis
2) Patients with massive pleural or pericardial effusion,or ascites
3) Patients with active severe infections
4) Cases with past history of administration of HER related agents
5) Impossible cases with oral administration
6) Patients with active opthalmological disease
7) Pregnancy or lactation
8) Patients with symptomatic brain metastasis
9) Patients with active concomitant malignancy
10) Patients with uncontrollabe diabetes mellitus
11) Patients with uncontrollable complications
12) Inappropriate patients for this study judged by the physicians

Target sample size

38

Name of lead principal investigator

1st name
Middle name
Last name	Akihito Yokoyama

Organization

Kochi University, School of Medicine

Division name

Department of Hematology and Respiratory Medicine

Zip code

Address

Kohasu, Okocho, Nankoku city, Kochi, 783-8505, Japan

TEL

088-880-2345

Email

im25@kochi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tetsuya Kubota

Organization

Kochi University, School of Medicine

Division name

Department of Hematology and Respiratory Medicine

Zip code

Address

Kohasu, Okocho, Nankoku city, Kochi, 783-8505, Japan

TEL

088-880-2345

Homepage URL

Email

im25@kochi-u.ac.jp

Institute

Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine

Institute

Department

Personal name

Organization

None

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

高知大学医学部付属病院（高知県）、高知医療センター（高知県）、国立病院機構高知病院（高知県）、高知赤十字病院（高知県）

Date of disclosure of the study information

2009

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://file.scirp.org/Html/2-2560032_42972.htm

Number of participants that the trial has enrolled

Results

9th JSMO annual meeting 2011
[Purpose] To evaluate the efficacy and safety of erlotinib in patients with previously treated non-small cell lung cancer (NSCLC), a phase II trial was studied in Kochi prefecture.[Patients and methods] Patients with stage IIIB/IV NSCLC and performance status 2 or lower, previously treated with 1 or 2 non- EGFR-TKI regimens were eligible. The enrollment has started since august 2009. Patients received Erlotinib (150mg/day) until disease progression or intolerable toxicity. Primary end point was the response rate (RR). In addition, disease control rate (DCR), progression free survival (PFS), and safety were evaluated.[Results] Thirty eight patients were enrolled, and 32 patients were evaluated. Median age was 69 years (range, 57 years to 80 years). Characteristics of patients were as follows: men/women, 21/11; PS0/1/2, 11/16/5; adenocarcinoma/ non-adenocarcinoma, 23/9. The objective RR and DCR were 31% and 65%, respectively. Twenty one patients could be evaluated for EGFR status (9 mutated/ 11 wild type). The RR of EGFR mutated patients was 67%, while wild type 17%. PFS of 24 cases were evaluated as 117 days. Major adverse events were tolerable skin toxicities, diarrhea, and stomatitis.[Conclusion] Erlotinib was efficacious in patients with previously treated NSCLC. Efficacy and safety were similar to previous reports.

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

06

Month

08

Day

Date of IRB

Anticipated trial start date

2009

Year

07

Month

01

Day

Last follow-up date

2011

Year

12

Month

01

Day

Date of closure to data entry

2011

Year

12

Month

01

Day

Date trial data considered complete

2011

Year

12

Month

01

Day

Date analysis concluded

2013

Year

03

Month

31

Day

Other related information

Advances in Lung Cancer
Vol.3 No.1(2014), 10-20.
DOI:10.4236/alc.2014.31002

Registered date

2009

Year

11

Month

09

Day

Last modified on

2014

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003328