UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002476 |
|---|---|
| Receipt number | R000002872 |
| Scientific Title | A multicenter phaseII study of FOLFIRI as FOLFOX refractory second-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with honozygous for UGT1A1: (FLIGHT2) |
| Date of disclosure of the study information | 2009/09/10 |
| Last modified on | 2018/09/20 08:20:50 |
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Basic information
Public title
A multicenter phaseII study of FOLFIRI as FOLFOX refractory second-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with honozygous for UGT1A1: (FLIGHT2)
Acronym
A multicenter phaseII study of second-line FOLFIRI for metastatic colorectal cancer(FLIGHT2)
Scientific Title
A multicenter phaseII study of FOLFIRI as FOLFOX refractory second-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with honozygous for UGT1A1: (FLIGHT2)
Scientific Title:Acronym
A multicenter phaseII study of second-line FOLFIRI for metastatic colorectal cancer(FLIGHT2)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the tumor response rate, the incidence and severity of adverse events during second-line chemothrapy of FOLFIRI in patients with metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
(1) response rate
(2) incidence and severity of adverse events
Key secondary outcomes
(1) overall survival (OS), progression-free survival (PFS)
(2) Evaluation of the causal relationship of each adverse event
(3) To investigate genetic variation of UGT1A1 and correlation with the toxicities of CPT-11
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
On Day 1, patients treated with FOLFIRI therapy received a 2-hour intravenous infusion of CPT-11 (150 mg/m2) combined with 1-LV (200 mg/m2), followed by a rapid intravenous infusion of 5-FU (400 mg/m2), and then a 46-hour continuous infusion of 5-FU (2,400 mg/m2). This regimen comprised one course of therapy and was repeated once every 2 weeks. Cycles of treatment will be continued for this study until disease progression (PD) occurs.
Patients will undergo UGT1A1 genotyping before starting to receive the protocol treatment. As recommended in the US prescribing information for Camptosar;, the starting dose of CPT-11 will be reduced to 100 mg/m2 in patients who are homozygous for the *28 allelic variant of UGT1A1 (further reduced to 75 mg/m2 in such patients aged 76-80 years). No dose adjustments will be made in patients who undergo UGT1A1 genotyping after starting to receive the protocol treatment.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histopathologically proven colon carcinoma or rectal carcinoma.
(2) Advanced or recurrent disease that is not amenable to curative resection.
(3) Failure to first-line chemotherapy with FOLFOX.
(4) At least 2 weeks after the last course of FOLFOX.
(5) At least 4 weeks after surgery.
(6) ECOG performance status of 0-1.
(7) Age between 20 and 80 years.
(8) Life expectancy of at least 12 weeks.
(9) Presence of at least one measurable lesion (outside the radiation field). A measurable lesion is defined as one that can be measured in a single dimension by palpation (together with a scale-containing radiographic image that permits objective assessment of the lesion size), CT, MRI, or any other radiographic method and which has a larger diameter >=2 cm (or >=1 cm and >=twice the slice width when measured by MRI or spiral CT).
(10) Adequate function of vital organs (e.g., bone marrow, heart, lungs, liver, and kidneys), as demonstrated by laboratory data obtained within 14 days of enrollment that are in the following ranges:
White blood cell count: 3,000-12,000/mm3.
Neutrophil count: >=1,500/mm3
(calculated from the white blood cell count and the differential neutrophil count [%]).
Platelet count: >=100,000/mm3.
Serum bilirubin: =<1.50 mg/dL.
AST and ALT: =<100 IU/L or 100 U/L.
Serum creatinine: =<1.20 mg/dL.
(11) Written informed consent.
Key exclusion criteria
(1) Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment.
(2) A history of severe drug allergy.
(3) Pleural effusion, ascites, or pericardial effusion requiring drainage.
(4) Active (e.g., clinically significant) infection.
(5) Confirmed or clinically suspected brain metastasis.*1
(6) Involvement of the central nervous system.
(7) Presence of bone metastasis as the sole metastasis.
(8) Any other concurrent malignancy, excluding metachronous malignancy that has been confirmed to have been cured.*2
(9) Uncontrolled hypercalcemia.
(10) Uncontrolled hypertension (despite antihypertensive medication).
(11) Uncontrolled diabetes mellitus.
(12) Any significant electrocardiographic abnormality or clinically significant heart disease.*3
(13) Fresh gastrointestinal bleeding.
(14) Intestinal paralysis or obstruction.
(15) Diarrhea (watery stools).*4
(16) Positivity for HIV antibody.
(17) Current treatment with atazanavir sulfate.
(18) Current treatment with phenytoin, warfarin potassium, or flucytosine.
(19) Pregnant or breast-feeding women, women of childbearing potential, women who wish to become pregnant, or men who wish to have a child with their female partners.
(20) Current participation in any other clinical trial/study.
(21) Any other condition that disqualifies the patient from the study in the opinion of the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Mishima |
Organization
Aichi Medical University
Division name
Cancer Center
Zip code
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
hmishima@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mai Hatta |
Organization
Nagoya University Graduate School of Medicine
Division name
Young Leaders'Program
Zip code
Address
65 Tsurumai Showa-ku Nagoya
TEL
052-744-2442
Homepage URL
m-hatta@med.nagoya-u.ac.jp
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network
Institute
Department
Personal name
Funding Source
Organization
NPO Epidemiological and Clinical Research Information Network
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2009 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
RESULTS:
The overall response rate was 12% for all 50 evaluable patients; 31 patients (62.0%) had stable disease, and only in 12 (24.0%) did disease progress. The median progression-free survival was 5.8 months. The tolerance treatment was acceptable, with only 15 out of 50 patients (30%) experiencing grade 3/4 neutropenia, and grade 4 thrombocytopenia was observed in only one case. Grade 3 non-hematological adverse reactions included stomatitis in three, diarrhea in one, and a clinically insignificant increase in serum alkaline phosphatases in one patient, respectively. There was no definite relation between the UGT1A1*28 polymorphism and toxicity.
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
| 2005 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 07 | Month | 01 | Day |
Other
Other related information
Anticancer Res. 2014 Jan;34(1):195-201.
Prospective phase II trial of second-line FOLFIRI in patients with advanced colorectal cancer including analysis of UGT1A1 polymorphisms: FLIGHT 2 study.
Hirata K, Nagata N, Kato T, Okuyama Y, Andoh H, Takahashi K, Oba K, Sakamoto J, Hazama S, Mishima H.
Management information
Registered date
| 2009 | Year | 09 | Month | 10 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002872
