EUCTR2009-011899-30-LVActive, not recruitingNot Applicable
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Amgen Inc
- Enrollment
- 800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Disease-related
- •Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum
- •Locally-advanced or metastatic disease by radiographic evaluation (CT, MRI)
- •o Measurable disease as defined by revised RECIST Criteria (v1.1) criteria (see Appendix F)
- •Subject has not previously received chemotherapy for locally-advanced or metastatic CRC
- •o Subject may have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent/metastatic disease was documented.
- •It is recommended that if progression occurred after 6 months but within 12 months following completion of adjuvant FOLFOX chemotherapy, subjects should receive FOLFIRI + bevacizumab as first-line chemotherapy, and vice versa. If > 12 months has elapsed before progression occurs, subjects may receive FOLFOX + bevacizumab or FOLFIRI + bevacizumab at physician’s discretion, regardless of what was received adjuvantly.
- •ECOG performance status 0-2 (see Appendix E)
- •4.1.2 Demographic
- •Age of 18 years or over
- •4.1.3 Laboratory
- •Adequate organ and marrow function as defined below:
- •Absolute neutrophil count (ANC) at least 1.5 x 109/L
- •Platelet count at least 100 x 109/L
- •Bilirubin = 1.5 times upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN or AST and ALT = 5.0 x ULN if attributable to liver metastasis
- •An in-range INR (in-range is usually defined as between 2 and 3) for
- •subjects on a stable dose of oral anticoagulant or stable dose of low
- •molecular weight heparin
- •Subject has no active bleeding or pathological condition that carries high risk of bleeding (eg, tumor involving major vessels or known varices). If a suspicion of bleeding diathesis exists, a bleeding time should be performed.
- •Creatinine = 1.5 times ULN
- •4.1.4 General
- •Written informed consent obtained
- •Afebrile on day 1 of cycle 1
- •Must be able and willing to comply with study and/or follow-up procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 320
Exclusion Criteria
- •Disease-related
- •Known brain metastases
- •History of another primary malignancy less than/equal to 5 years prior to randomization, with the exception of non-melanoma skin cancer, carcinoma in situ of uterine cervix, and prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Prior major surgical procedure less than 28 days prior to day 1 of cycle 1 chemotherapy dosing); anticipated need for major surgical procedure during the 4 cycle treatment period of the study
- •Fine needle aspirations or core biopsies within 7 days prior to day 1 of cycle 1 chemotherapy dosing
- •Serious nonhealing wound, ulcer, or bone fracture, or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of cycle 1
- •Uncontrolled high blood pressure, history of labile hypertension, uncontrolled congestive heart failure, unstable angina within the past 3 months, myocardial infarction or history of stroke within the past 12 months, unstable symptomatic arrhythmia requiring medication, or clinically significant peripheral vascular disease
- •History of clinically significant bleeding within 6 months prior to randomization
- •History of arterial or venous thromboembolism within 6 months prior to randomization
- •History of other disease including uncontrolled diabetes, serious active or uncontrolled infection, metabolic dysfunction; physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the prescribed therapy or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
- •4.2.2 Laboratory
- •Proteinuria > 1+, or total quantitative protein > 500 mg protein/day as determined by 24-hr urine collection
- •4.2.3 Medications
- •Prior radiotherapy unless treatment was limited to the target lesion and only 1 measurable lesion was treated. Progression of the irradiated lesion must be demonstrated. Subjects may not have received prior radiotherapy to greater than 25% of bone marrow. Radiation must have concluded = 4 weeks prior to enrollment. Prior radio-sensitizing chemoradiation will be allowed as long as it was concluded = 4 weeks prior to enrollment.
- •o Radiotherapy to non-target lesions for pain control will be allowed
- •Prior bevacizumab use or other agents targeting VEGF
- •Concurrent use of other biological agents
- •Use of systemic anti-infectives for active infection, during the 3 calendar days before starting study chemotherapy and bevacizumab or planned during the study treatment period
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation (during the study treatment period) in an experimental therapeutics study other than this protocol
- •Female subjects who are pregnant or lactating or men and women of
- •reproductive potential not willing to employ an effective method of birth control during treatment and for 20 weeks for women, and 30 weeks for men after discontinuing study treatment
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, oxaliplatin, or leucovorin, including known sensitivity to E.Coli derived products (eg, Filgrastim, HUMULIN insulin, L-asparaginase)
- •Known dihydropyrimidine dehydrogenase deficiency
Investigators
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