Unique ID issued by UMIN | UMIN000009698 |
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Receipt number | R000011370 |
Scientific Title | Phase II crinical trial of cetuximab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer |
Date of disclosure of the study information | 2013/01/07 |
Last modified on | 2018/06/25 14:56:14 |
Phase II crinical trial of cetuximab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer
Cetuximab Rechallenge
Phase II crinical trial of cetuximab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer
Cetuximab Rechallenge
Japan |
Colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
YES
This phase II prospective study aims
to investigate the activity of a retreatment with a cetuximab-based therapy.
Safety,Efficacy
Response rate(RR)
Progression free survival(PFS)
Overall survival(OS)
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
This is a multicentric phase II trial that examines patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab- plus FOLFOX/FOLFIRI therapy and then a progression of disease, during cetuximab-based therapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another Cetuximab based chemotherapy.
20 | years-old | <= |
Not applicable |
Male and Female
1)Histopathological confirmation of Adenocarcinoma
2EGFR expression confirmed by immunohistochemistry either in the primary tumor or in metastatic tumor lesion
3)KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
4)Patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab based chemotherapy and then a progression of disease or intolerable of adverse events, during cetuximab based chemotherapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another cetuximab chemotherapy.
5)Age of 20 or more years old
6)ECOG performance status of 0 to 2
7)Presence of at least one measurable lesion according to RECIST
8)Sufficient function of important organs
1. WBC:>= 2,000 /mm3
2. Neu: >= 1,500 /mm3
3. Platelet: >= 75,000 /mm3
4. Hemoglobin: >= 8.0 g/dL
5. Sr.bil : <= 2.5 mg/dL
6. AST, ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST, ALT : <= ULNx5.0)
7. Serum creatinine: <= ULNx1.5
9)Expected more than 3 months survival
10)With written informed consent
1)Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2)Patients with brain metastasis which have symptoms or patients with history of brain metastasis
3)Severe wattery diarrhea
4)Severe infectious disease
5)Severe complications (interstitial lung disease or pulmonary fibrosis, kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension)
6)Severe carcinomatous ascites, pleural effusion or pericardial cavity effusion
7)Pregnant or lactating women or women of childbearing potential, and no birth-control
8)Patients with history of serious hypersensitivity
25
1st name | |
Middle name | |
Last name | Toshiyoshi Fujiwara |
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Department of Gastroenterological Surgery
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
086-235-7257
1st name | |
Middle name | |
Last name | Takeshi Nagasaka |
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Department of Gastroenterological Surgery
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
086-235-7257
Okayama Molecular Target-Based Drugs Society for Cancer of the Colon and Rectum
Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Self funding
NO
2013 | Year | 01 | Month | 07 | Day |
Unpublished
Terminated
2012 | Year | 12 | Month | 19 | Day |
2013 | Year | 01 | Month | 07 | Day |
2013 | Year | 01 | Month | 05 | Day |
2018 | Year | 06 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011370
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