Colorectal cancer
Conditions
Interventions
Level1 First dose Cetuximab: 400 mg/m2 div day1 U3-1565: 24 mg/kg div day1 From second dose on Cetuximab: 250 mg/m2 div. day1,8 U3-1565: 16 mg/kg div day1 q2w Level0 First dose Cetuxim
Sponsors
St. Marianna University School of Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed KRAS (EXON 2 codon12/13) wild-type colorectal adenocarcinoma 2) Unresectable colorectal cancer 3) Aged 20 years or over 4) ECOG Performance status (PS): 0, 1 5) 1 or more target lesions (RECIST ver 1.1) 6) Previous chemotherapy for unresectable colorectal cancer 1. received 5-FU 2. received oxaliplatin 3. received irinotecan 4. received cetuximab or panitumumab, and resistant to either 5. received 2 more regimens 7) Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment 1. Neutrophil count: 1,200/mm3 or above 2. Hemoglobin: 8.0 g/dL or above 3. Platelet count: 75000/mm3 or above 4. Total bilirubin: 2.0 mg/dL or less 5. AST (GOT): 100 IU/L or less 6. ALT (GPT): 100 IU/L or less 7. Serum creatinin: 2.0 mg/dL or less 8) No blood transfusion within 14 days prior to enrollment 9) Grade 1 or less of acute adverse events or recovered to the baseline before the previous treatment 10) Not pregnant in lactating female 11) Written infromed consent
Exclusion criteria
Exclusion criteria: 1) Any chemotherapy within 2 weeks prior to enrollment 2) Any surgery or radiation within 4 weeks prior to enrollment 3) Any investigatilnal drug within 4 weeks prior to enrollment 4) Previous administration of U3-1565 5) Hypersensitivity to U3-1565 or its additives 6) Metastasis to central nervous system 7) Pleural effusion, ascites or pericardial effusion under drainage 8) Other currently active malignancies excluding malignancies that are disease free for more than 3 years or carcinoma-in -situ deemed cured by adequate treatment 9) History of any severe medical condition 10) HBs Ag: positive, HCV Ab: positive 11) Continuous systemic steroids or immunosuppressant drug 12) Active bleeding 13) No contraception 14) No will or impossible to follow the protocol 15) Investigator considered the patients inappropriate to the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of DLT(Dose limiting toxicity) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters Proportion and severity of adverse events Response rate: RR Duration of response: DOR Disease control rate: DCR Progression free survival: PFS Overall survival: OS | — |
Countries
Japan
Contacts
Public ContactTakako Nakajima
St. Marianna University School of Medicine Hospital Department of Medical Oncology
Outcome results
None listed