Unique ID issued by UMIN | UMIN000004507 |
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Receipt number | R000005388 |
Scientific Title | Pharmacogenomic analysis for Phase II clinical trial of the third-line Cetuximab and irinotecan or Cetuximab therapy for patients with KRAS wild type unresectable/recurrent colorectal cancer |
Date of disclosure of the study information | 2010/11/08 |
Last modified on | 2018/10/31 22:39:11 |
Pharmacogenomic analysis for Phase II clinical trial of the third-line Cetuximab and irinotecan or Cetuximab therapy for patients with KRAS wild type unresectable/recurrent colorectal cancer
CEREB trial
CEtuximab, REsearch on Biomarker
Pharmacogenomic analysis for Phase II clinical trial of the third-line Cetuximab and irinotecan or Cetuximab therapy for patients with KRAS wild type unresectable/recurrent colorectal cancer
CEREB trial
CEtuximab, REsearch on Biomarker
Japan |
Colorectal Cancer
Gastroenterology |
Malignancy
YES
To search the factors which influence the efficacy and safety of the combination regimen of Cetuximab puls irinotecan and Docetaxel alone regimen in patients with previously treated KRAS wild type unresectable/recurrent colorectal cancer
PK,PD
Exploratory
Phase II
Adverse events of grade 3/4
Response Rate, Progression free survival, Overall survival,Time to progression, The incidence of grade 3/4 Skin toxicity,Time to progression of irinotecan combined regimen(A group)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Chemotherapy(Cetuximab +irinotecan or cetuximab)
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Unresectable advanced or recurrent colorectal cancer.
2) KRAS wild type
3) Histologically proved adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of the colon or rectum. In the recurrent case, histology of the primary site must have been confirmed in the past. Additional histological confirmation of metastatic or recurrent site is not necessary.
4) Age more than 20years and less than 75 years.
5) ECOG performance status of 0,1 or 2.
6) Survival time more than 2 months after registration expect
7) At least one measurable lesion based on the RECIST criterion.
8) Irinotecan and fluoropyrimidine and oxaliplatin resistant or intorerable case
9) No prior anti-EGFR therapyies
10) Required baseline laboratory parameters (within 7 days before registration):
Hb more than 8.0g/dl
WBC more than 3000 and WBC less than 12000/ul
Plt more than 75,000/ul
T-Bil less than 1.5mg/dl
GOT less than 100 IU/l
GPT less than 100 IU/l
Cre less than 1.5mg/dl
11) Required no therapy time from prior therapy to registration
Surgical procedure over 4 weeks before registration
Radiation :4 weeks
Chemotherapy:4 weeks
12) Signed informed consent of the patient for the registration.
1) active other malignancies within 5 years
2) history of the severe drug hypersensitivity
3) clinically significant infectious disease(body temperature less than 38.0 degrees)
4) severe complications (ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure and so on)
5) Patients who have abnormal findings on ECG and need any treatment (within 4 weeks before the registration.)
6) Moderate/severe pleural effusion or ascites
7) Symptomatic brain metastasis
8)Patient need transfusion because GI bleeding
9) Uncontrolled watery diarrhea.
Watery colostomy output without trouble with patient's daily living is allowed.
16) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse.
17) Any other cases who are regarded as inadequate for study enrollment by the investigator.
60
1st name | |
Middle name | |
Last name | Ken Kato KK |
National Cancer Center Hospital
Gastrointestinal Oncology Division
5-1-1, Tsukiji, Chuo-ku, Tokyo
0335422511
NCC_IRBoffice@ml.res.ncc.go.jp
1st name | |
Middle name | |
Last name | Ken Kato |
National Cancer Center Hospital
Gastrointestinal Oncology Division
5-1-1, Tsukiji, Chuo-ku
03-3542-2511
kenkato@ncc.go.jp
National Cancer Center Hospital
Ministry of Health, Labor and Welfare
Japanese Governmental office
NO
2010 | Year | 11 | Month | 08 | Day |
Unpublished
Completed
2008 | Year | 12 | Month | 09 | Day |
2009 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2010 | Year | 11 | Month | 05 | Day |
2018 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005388
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