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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001730
Receipt No. R000002068
Scientific Title Pilot study of gefitinib and irinotecan in young patients With Relapsed or Refractory Cancer
Date of disclosure of the study information 2009/02/23
Last modified on 2011/05/23

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Basic information
Public title Pilot study of gefitinib and irinotecan in young patients With Relapsed or Refractory Cancer
Acronym Ir2 for Relapsed Pediatric and AYA cancer pilot trial
Scientific Title Pilot study of gefitinib and irinotecan in young patients With Relapsed or Refractory Cancer
Scientific Title:Acronym Ir2 for Relapsed Pediatric and AYA cancer pilot trial
Region
Japan

Condition
Condition Relapse/ refractory pediatric and adolescent and young adult cancer
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To assess dose limiting toxicity of gefitinib and irinotecan combination regimen in from children to young adult
2. To characterize the pharmacokinetics of irinotecan and gefitinib in their concurrent administration in young population
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes incidence of dose limiting toxicity
Key secondary outcomes incidence of adverse event, pharmacokinetic parameter,
feasibility of concurrent administration of gefitinib and irinotecan

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 gefitinib and irinotecan regimen in which gefitinib 112.5mg/m2/day p.o. on days 1-12, irinotecan 30mg/m2 DIV over 30 min on days 1-5, and cefixime 8mg/kg/day p.o. on days -1-14 on to be repeated every 3 weeks until progression
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
1 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria 1. neuroblastoma, retinoblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, osteosarcoma, glioma, meduloblastoma, germ cell tumor
2. relapse or progression following disease specific first-line standard chemotherapies
3. no prior use of irinotecan, gefitinib, erlotinib, or cetuximab
4. evidence of progression in clinical signs or symptoms or on imaging studies
5. > 14 days since prior antitumor cytotoxic agents except nitrosourea and > 28 days since prior nitrosourea
6. >= 14 days for local palliative radiation and > 6 months must have
elapsed if prior craniospinal XRT or if >= 50% radiation of pelvis and >= 8 weeks must have elapsed if conventional radiation for brain tumor and >= 6 weeks
must have elapsed if other substantial BM radiation
7. > 14 days since prior surgery (containing open biopsy)
8. 0-2 in ECOG PS
9. no findings of interstitial pneumonia on CT
11. no signs or symptoms equivalent to CTC-AE Grade2 diarrhea
12. confirming the following laboratory results within 14 days
(1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration)
(2) Platelet count >= 75,000/mm~3 (platelet transfusions allowed)
(3) serum total Bilirubin <= 1.2mg/dl
(4) ALT <= 100 IU/l
(5) Creatinine adjusted according to age as follows:
<= 0.6 mg/dl (1 year-23 months)
<= 0.8 mg/dl (2 years-5 years)
<= 0.9 mg/dl (6 years-9 years)
<= 1.1 mg/dl (10 years-12 years [male])
<= 1.0 mg/dl (10 years-12 years [female])
<= 1.5 mg/dl (13 years-15 years [male])
<= 1.2 mg/dl (13 years and over [female])
<= 1.7 mg/dl (16 years and over [male])
13. legal adult: Written informed consent
14. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian
15. 15 years and under: written informed consent from legal guardian
Key exclusion criteria 1. >4 weeks since prior CYP3A4 inducer uptake
2. >1 week since prior CYP3A4 inhibitor uptake
3. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment
4. Active infection requiring systemic medication
5. abnormality in electrocardiogram tested within 28 days, requiring intervention
6. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion
7. Women during pregnancy or breast-feeding
8. Psychosis
9. Systemic steroids or immunosuppressants medication except for continuous steroid use for increased intracranial pressure and/or brain edema
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kawamoto
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name pediatric division/ clinical reserch division
Zip code
Address 18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL 03-3823-2101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kawamoto
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name pediatric division/ clinical reserch division
Zip code
Address 18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL 03-3823-2101
Homepage URL http://www.nposuccess.jp/datacenter/index.html
Email

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
pediatric division/musculoskeltal oncology division/ neurology division
Institute
Department

Funding Source
Organization Group for for "Investigation of feasibility evaluation for clinical application of off-label drugs based on systematic series of clinical trials in pediatric solid malignancy"
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor NPO SUCCESS Support Center for Therapeutic Development
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
2009 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://abstract.asco.org/AbstView_102_80999.html
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
2009 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 23 Day
Last modified on
2011 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002068

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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