UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004639 |
|---|---|
| Receipt number | 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 13:25:33 |
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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
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
Sponsor or person
Institute
Shimane university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005529
