UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004639
Receipt No. R000005529
Scientific Title Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with Irinotecan(CPT-11) and Erlotinib(Tarceva) for Recurrent Lung Cancer
Date of disclosure of the study information 2010/12/02
Last modified on 2012/10/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition recurrent non small cell lung cancer after chemotherapy
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
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

Assessment
Primary outcomes response rate
Key secondary outcomes progression free survival, safety, QOL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Shimane university hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kumamoto university
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2010 Year 11 Month 30 Day
Last modified on
2012 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005529

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.