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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004629
Receipt No. R000005523
Scientific Title Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer
Date of disclosure of the study information 2010/11/27
Last modified on 2016/05/31

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Basic information
Public title Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer
Acronym Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer
Scientific Title Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer
Scientific Title:Acronym Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer
Region
Japan

Condition
Condition Clinical stage IV non squamous non small cell lung cancer chemotherapy naive patients over 70years old
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Phase I trial Decide MTD and RD about the Carboplatin plus Pemetrexed to elderly non small non squamous cell lung cancer patients
Phase II trial Study efficacy and safety about the Carboplatin plus Pemetrexed to elderly non small non squamous cell lung cancer patients
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 1 year survival rate, 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 We register patients in this trial from May 2010 to April 2012 and we will follow them another two years. We administer Carboplatin AUC4 plus Pemetrexed 500mg/m2 every 3 weeks and determine the RD after we assess the DLT in phase I trial. In phase II trial, we administer Carboplatin plus Pemetrexed from 2 to 6 courses according to the RD. We expect 55 patients to entry this phase II trial.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosis of non small cell lung cancer and non squamous cell lung cancer confirmed either histologically or cytologically
Recurrence after operation or clinical stage IV
No prior chemotherapy
Elderly patients over 70 years old
ECOG Performance status 0-1
Adequate bone marrow reserve and organ function
A measurable lesion according to the Response Evaluation Criteria in Solid Tumors
A projected life expectancy of at least 3 months
Written informed consent
Key exclusion criteria Squamous cell carcinoma
Radiation therapy to primary cancer
SVC syndrome
Severe drug allergy
Severe pleural effusion or uncontrollable pleural effusion
Severe ascites or pericardiac effusion
Active infection
Symptomatic brain metastasis
Active concomitant malignancy
Active mental illness
Target sample size 67

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiichiro Sasaki
Organization Kumamoto university hospital
Division name Respiratory medicine
Zip code
Address 1-1-1, Honjyo, Kumamoto city, Kumamoto prefecture, Japan
TEL 0963735012
Email saji@gpo.kunanoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Sakata
Organization Kumamoto university hospital
Division name Respiratory medicine
Zip code
Address 1-1-1, Honjyo, Kumamoto city, Kumamoto prefecture, Japan
TEL 0963735012
Homepage URL
Email sakata-1027@hotmail.co.jp

Sponsor
Institute Kumamoto 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
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 11 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.karger.com/Article/Abstract/369255
Number of participants that the trial has enrolled
Results
Oncology. 2015;88(4):201-7. doi: 10.1159/000369255. Epub 2014 Dec 6.

Results
Grade 3 infection as a dose-limiting toxicity was observed at a carboplatin dose of AUC 6. We therefore determined a carboplatin dose of AUC 5 and a pemetrexed dose of 500 mg/m2 as the recommended doses from this study. The pharmacokinetic study showed a significant inverse correlation between the AUC of pemetrexed and the creatinine clearance.

Conclusions
For elderly chemotherapy-naive patients with advanced nonsquamous NSCLC, the combination of carboplatin AUC 5 plus pemetrexed 500 mg/m2 is recommended as a promising regimen, however, a reduction of the pemetrexed dose may be required for patients with renal dysfunction because of the high risk of hematotoxicities. 
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 Completed
Date of protocol fixation
2010 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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 27 Day
Last modified on
2016 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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