UMIN-CTR Clinical Trial

Public title

Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with Irinotecan(CPT-11) and Erlotinib(Tarceva) for Recurrent Lung Cancer

Acronym

Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with CPT-11 and Erlotinib for Recurrent Lung Cancer

Scientific Title

Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with Irinotecan(CPT-11) and Erlotinib(Tarceva) for Recurrent Lung Cancer

Scientific Title:Acronym

Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with CPT-11 and Erlotinib for Recurrent Lung Cancer

Region

Japan

Condition

recurrent non small cell lung cancer after chemotherapy

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Phase I trial decides maximum-tolerated dose (MTD) and recommended dose (RD) about the CPT-11 and Erlotinib combination therapy to recurrent non small cell lung cancer patients.
Phase II study investigates the efficacy and the safety of the combination therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

response rate

Key secondary outcomes

progression free survival, safety, QOL

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

No intrapatient dose escalation is allowed. At least three patients are enrolled at each dose level. If a DLT is observed in one of the first three patients, then three additional patients
are enrolled at the same dose level. DLTs are assessed during the first chemotherapy cycle. Dose escalation is discontinued and the DLT level will be reached if at least 50% of the patients treated at that level developed a DLT
(e.g. at least two of three, or three of six patients). The recommended dose (RD) level is defined as the first level below the DLT dose level.
We expect 45 patients to entry this phase II trial.
Study period is 2 years.
We follow the patients for 1 year from the last registration.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Diagnosis of non small cell lung cancer confirmed either histologically or cytologically.
Recurrent case after chemotherapy.(2nd line -)
ECOG performance status 0-1.
CPT-11 and Erlotinib are not administerd in the previous chemotherapy.
Over 18 years old.
Adequate bone marrow function and organ function.
Life expectancy is more than 3 months.
Patient who doesn't have UGT1A1*28 homozygote.
Patients who received investigation of EGFR-mutaion.
Written informed consent.

Key exclusion criteria

Active infection.
Severe DM.
Severe heart disease, angina, myocadial infarction before 3 month.
Active peptic ulcer.
Concomitant malignancy.
Severe neural disease.
Severe comorbidity.
Interstitial pneumonia in chest CT.
Symptomatic brain metastasis.
Severe ascites.
Severe pleural effusion.
Severe pericardial effusion.
Impaired blodd coagulation.
Pregnant, potential pregnant, or lactating.
Severe drug hypersensitivity.
Judged inappropriate for the trial by the doctor in charge

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Tamio Okimoto

Organization

Shimane university hospital

Division name

Clinical oncology and Respiratory medicine

Zip code

Address

89-1, Enya-cho, Izumo city, Shimane prefecture, Japan

TEL

0853-20-2581

Email

Name of contact person

1st name
Middle name
Last name	Tamio Okimoto

Organization

Shimane university hospital

Division name

Clinical oncology and Respiratory medicine

Zip code

Address

89-1, Enya-cho, Izumo city, Shimane prefecture, Japan

TEL

0853-20-2581

Homepage URL

Email

Institute

Shimane university hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Kumamoto university

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

12

Month

02

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

Terminated

Date of protocol fixation

2010

Year

08

Month

24

Day

Date of IRB

Anticipated trial start date

2010

Year

09

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

11

Month

30

Day

Last modified on

2012

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005529