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) - ND
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10052362Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer
- Registration Number
- EUCTR2009-011899-30-IT
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 800
4.1.1 Disease-related Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum Locally-advanced or metastatic disease by radiographic evaluation (CT, MRI) − 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 − 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 The full list is available in the procotol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
4.2.1 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 (eg. implantation of venous access device, fine needle aspirations, or core biopsies) 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 The full list is available in the procotol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of pegfilgrastim, as compared with placebo in reducing the incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer treated with bevacizumab and either FOLFOX or FOLFIRI.;Secondary Objective: Secondary endpoints include: OS PFS Time to progression (TTP) ORR Incidence of grade 4 FN Incidence of grade 3/4 neutropenia Incidence of grade 4 neutropenia;Primary end point(s): The primary endpoint is the incidence of grade 3/4 FN during the study treatment period.
- Secondary Outcome Measures
Name Time Method