Recurrent or metastatic colorectal cancer
Conditions
Interventions
Treatment is administered every 2 weeks until evidence of progression, unacceptable toxicity or patient refusal. During the treatment, image assessment is repeated every 2 months at least.
Sponsors
Hyogo Cancer Center, Dept. of Gastrointestinal and Hepatobiliary Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.histologically proven unresectable metastatic colorectal cancer 2.at least one measurable leasion (CT and/or MRI, with maximum axis 20mm or more in case of 10mm slice or less, with maximum axis 10mm or more in case of 5mm slice or less) 3.refractory for oxaliplatin-based 1st line chemotherapy. Within 28 days after confirmation of disease progression in 1st line treatment. 4.KRAS status is investigated 5.age: 20-75 years old 6.ECOG PS: 0-2 7.adequate major organ functions 8.expected 3 months or over survival 9.written informed consents
Exclusion criteria
Exclusion criteria: 1.clinical or radiological evidence of CNS metastases 2.current or previous (at least once within the last 1 year/ twice or more) history of arterial thromboembolism such as cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to enrollment/ fine-needle aspiration cytology within 7 days prior to enrollment 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.evidence of bleeding diathesis, coagulopathy or abnormal coagulation factor (PT-INR>=1.5 within 14 days prior to enrollment) 7.current or recent (within 10 days prior to enrollment) ongoing treatment with anticoagulants for therapeutic purposes 8.ongoing treatment with aspirin (>= 325 mg/day), nonsteroid anti-inflammatory drug or adrenocortical steroid 9.clinically significant (i.e. active) cardiovascular disease (NCI-CTCAE grade 2 or worse), or past or current history (at least once within the last 1 year/ twice or more) of myocardial infarction 10.renal failure need to treat 11.serious complication (uncontrolled ulcer, hypertension, diabetes mellitus, infection, diarrhea,etc) 12.uncontrolled pleural effusion and/or ascites 13.past or current history (within the last 5 years) of malignant disease, except for the early cancer healed clearly 14.interstitial lung disease, or pulmonary fibrosis 15.history of organ transplantation 16.pregnancy, lactation and positive serum pregnancy test/no birth-control 17.serious drug hypersensitivity or history of drug allergy of 5-FU, l-LV and/or irinotecan 18.history of adverse reaction to fluorouracil in which DPD deficiency is suspected 19.any other cases who are regarded as inadequate for trial enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line overall response rate, safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line in KRAS wild-type and mutant population, respectively | — |
Countries
Japan
Contacts
Public ContactMasanori Toyoda
Sano Hospital Gastrointestinal Center
Outcome results
None listed