Status:
COMPLETED
A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC
Lead Sponsor:
EPS Corporation
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study to assess efficacy and tolerability of combination therapy FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic colorectal cancer.
Detailed Description
This is a single-arm, multicentre phase II study evaluating the efficacy and safety of Bevacizumab (BV) in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and leucovorin calcium ...
Eligibility Criteria
Inclusion
- Written Informed consent.
- Histopathologically proven diagnosis of colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
- Not resectable metastatic colorectal cancer
- Age at enrollment is \>= 20 and \<= 75 years
- ECOG PS \< 2 if age \< 70 years, ECOG PS = 0 if age = 71-75 years
- One or more measurable lesion in RECIST ver.1.1 criteria according to contrast enhanced CT chest / abdomen / pelvis diagnosis.
- Not previously treated with chemotherapy. ( Previous adjuvant by fluoropyrimidine monotherapy is allowed if more than 24 weeks have elapsed between the end of adjuvant therapy and first relapse.)
- Vital organ functions (listed below) are preserved within 2 weeks prior to entry. Data recorded nearest to the entry should be referred. Blood transfusion or erythropoiesis stimulating agents less than 2 weeks prior to the tests are not allowed.
- Neu. \>= 1,500/cubicmillimeter Pt. \>= 100,000/cubicmillimeter Hb. \>= 9.0 g/dL T-bil. \<= upper limit of normal (ULN)\*1.5 AST and ALT,ALP \<= upper limit of normal (ULN)\*2.5 (\<= ULN\*5 in case of liver metastasis) Serum creatinine \<= upper limit of normal (ULN) \*1.5 PT-INR \< 1.5 Proteinuria \<= 2+
- UGT1A1 genotype tested. Categorized into Wild or single Hetero.
Exclusion
- Previously treated with irradiation to bone marrow constituting 20% or more of irradiation field.
- Untreated brain metastases or spinal cord compression or primary brain tumors.
- History of CNS disease.\[except for asymptomatic Lacunar stroke\]
- Requiring chronic systemic corticosteroid treatment.
- Current or recent ongoing treatment with anticoagulants.
- Clinically significant cardiovascular disease for example cerebrovascular accidents, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication.
- Treatment with any investigational drug within 4 weeks.
- Patient with Uncontrolled hypertension, Uncontrolled diabetes, Uncontrolled diarrhea, \>=grade 1 peripheral neuropathy, Active peptic ulcer, Non-healing wound, Clinically important diseases.
- Major surgical procedure within 28 days prior to study treatment start, open biopsy, or significant traumatic injury, or anticipation of the need for major surgical procedure.\[except for implantation of central venous catheter and port system.\]
- Lack of physical integrity of the upper gastrointestinal tract.
- Pregnant women, lactating woman , positive by pregnancy test , wishing to become pregnant, and Sexually active males.
- Hepatitis B or hepatitis C. Evidence of HIV infection.
- Previous Chemotherapy for other organs.
- Other active co-existing malignancies.
- History / Presence of thrombosis within 1 year requiring medication.
- History / Presence of paralytic ileus, obstruction or gastrointestinal perforation.
- Malignant coelomic fluid required drainage.
- History of allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications.
- History of fluoropyrimidine severe side effects caused by DPD defect.
- Interstitial pneumonitis or pulmonary fibrosis.
- Evidence or requiring systemic treatment for Infectious disease.
- Patient who is judged by the investigator to be inappropriate for study participation for any reason.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02246049
Start Date
May 1 2014
End Date
February 1 2017
Last Update
June 19 2017
Active Locations (1)
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1
EPS Corporation
Shinjuku, Tokyo, Japan, 162-0814