Unique ID issued by UMIN | UMIN000015475 |
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Receipt number | R000017987 |
Scientific Title | Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer |
Date of disclosure of the study information | 2014/11/01 |
Last modified on | 2018/03/08 08:49:15 |
Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer
JACCRO CC-14 study
Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer
JACCRO CC-14 study
Japan |
KRAS or RAS wild-type metastatic colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To determin MTD and RD of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase I
Recommended Dose
Completion rate of the protocol treatment (Until 12 courses)
Time to Treatment Failure
Overall Survival
Progression Free Survival
Safety
Response Rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
FOLFOXIRI+Panitumumab (Until 12 courses)
Panitumumab 6mg/kg/bi-weekly
Irinotecan 165-125mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
Levofolinate 200mg/m2/bi-weekly
5-FU 3200mg/m2/bi-weekly
18 | years-old | <= |
Not applicable |
Male and Female
(1) Histologically confirmed colorectal cancer (Adenocarcinoma). (2) KRAS wild-type, or RAS wild-type. (3) Presence of evaluable lesion. (4) No prior chemotherapy or radiotherapy for unresectable primary tumor, metastases and lymphnode metastases. No prior therapy including surgery for reccurent lesions that should be the first relapse after surgery for primary or metastases tumors. (5) Age; more than 18 years old. (6) ECOG Performance status 0-1. (7) UGT1A1*6*28 wild type or single hetero. (8) Life expectancy of more than 3 months.(9) Patients have enough organ function for study treatment within 14 days before enrollment; 1) WBC>= 3,000/mm3, <12,000/mm3. 2) Neu>= 2,000/mm3. 3) PLT>= 100,000/mm3. 4) Hb>= 10.0g/dL. 5) Total Bilirubin<= 1.5mg/dL. 6) AST<= 100IU/L. 7) ALT<= 100IU/L. 8) Creatinine<= 1.5mg/dL. (10) Written informed consent.
(1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (3) Brain metastases. (4) Active infection. (5) Serious complication (Interstitial pneumonia, Chronic obstructive pulmonary, Idiopathic pulmonary fibrosis, Renal failure, Hepatic failure, Uncontrolled Deabetes, Uncontrolled hypertention, Angina requiring treatment, Cardiac failure, Jaundice). (6) Ileus or bowel obstruction. (7) Large quantity of pleural, abdominal or cardiac effusion. (8) diarrhea. (9) peripheral neuropathy greater than Grade 2. (10) Active viral hepatitis. (11) Administration of atazanavir sulfate. (12) History of severe allergy. (13) History of organ recipient. (14) History of myocardial infarction, unstable angina within 3 months prior to the registration. (15) Prior Panitumumab/Irinotecan/Oxaliplatin treatment. (Adjuvant therapy by Oxaliplatin is excluded) (16) severe mental disorders. (17) Systemic steroid user. (18) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (19) Any other cases who are regarded as inadequate for study enrollment by investigators.
18
1st name | |
Middle name | |
Last name | Akihito Tsuji |
Kobe City Medical Center General Hospital
Clinical oncology
Clinical oncology
078-302-4321
tsuji@kcho.jp
1st name | |
Middle name | |
Last name | Masashi Fujii |
Nonprofit Organization Japan Clinical Cancer Research Organization
Office
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
03-5579-9882
cc14.dc@jaccro.or.jp
Nonprofit Organization Japan Clinical Cancer Research Organization
Takeda Pharmaceutical Company Limited
Profit organization
Japan
NO
2014 | Year | 11 | Month | 01 | Day |
Published
Completed
2014 | Year | 10 | Month | 16 | Day |
2014 | Year | 11 | Month | 01 | Day |
2014 | Year | 10 | Month | 20 | Day |
2018 | Year | 03 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017987
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