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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00911170
Registration number
NCT00911170
Ethics application status
Date submitted
21/05/2009
Date registered
1/06/2009
Date last updated
29/12/2017
Titles & IDs
Public title
PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
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Secondary ID [1]
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20080259
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
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0
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Colon Cancer
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Colorectal Cancer
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0
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Fever
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Locally Advanced
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0
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Metastatic Colorectal Cancer
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0
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Neutropenia
0
0
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Rectal Cancer
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0
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Condition category
Condition code
Cancer
0
0
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Blood
0
0
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0
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pegfilgrastim
Treatment: Drugs - Placebo
Other interventions - Bevacizumab
Treatment: Drugs - Standard Chemotherapy
Placebo Comparator: Placebo - Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
Placebo Comparator: Pegfilgrastim - Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
Treatment: Drugs: Pegfilgrastim
Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product.
Treatment: Drugs: Placebo
Administered as a single subcutaneous injection using a pre-filled syringe.
Other interventions: Bevacizumab
5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle.
Treatment: Drugs: Standard Chemotherapy
Each participant received one of the following chemotherapy regimens at the discretion of treating physician:
FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy
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Assessment method [1]
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Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature = 38.0°C (= 100.4°F) and absolute neutrophil count (ANC) < 1.0 × 10^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature = 38.0°C (= 100.4°F), or • An ANC < 1.0 × 10^9/L in combination with: - documented sepsis or infection, OR - neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment.
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Timepoint [1]
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Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Median time from randomization to date of death caclulated using the Kaplan-Meier method. Participants were censored on the date of last contact (i.e., the date the participant was last known to be alive) if they were not known to have died.
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Timepoint [1]
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From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.
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Secondary outcome [2]
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Progression Free Survival
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Assessment method [2]
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Time from randomization to date of radiological disease progression or death from any cause, whichever event occurs first, calculated using the Kaplan-Meier method. Participants without either event by the analysis data cutoff date were censored on the date of their last evaluable disease assessment. Disease progression based on the investigator's assessment of radiographic scans using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Clinical progression without radiological assessment was not be considered a disease progression in this analysis. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
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Timepoint [2]
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From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.
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Secondary outcome [3]
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Time to Progression
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Assessment method [3]
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Time from randomization to date of radiological disease progression calculated using the Kaplan-Meier method. Participants without progression were censored on the date of their last radiographic tumor assessment. Disease progression based on the investigator's assessment of scans using the RECIST v1.1. Clinical progression without radiological assessment was not considered a disease progression. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
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Timepoint [3]
0
0
From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.
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Secondary outcome [4]
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Percentage of Participants With an Objective Response
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Assessment method [4]
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The percentage of participants with a complete response (CR) or partial response (PR) defined by the RECIST v1.1 criteria at any time during the study. Response was be determined by the investigator's assessment of radiographic scans. CR: Disappearance of all non-nodal target lesions and the disappearance of all non-nodal non-target lesions, and no new lesions. All nodal lesions must have reduction of short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters and no new lesions and/or unequivocal progression of existing non-target lesions, or, the disappearance of all non-nodal target lesions with persistence of one or more non-target lesion(s).
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Timepoint [4]
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From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.
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Secondary outcome [5]
0
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Percentage of Participants With Grade 4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy
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Assessment method [5]
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Grade 4 febrile neutropenia (FN) is defined as:
A temperature = 38.0ºC (= 100.4ºF) and absolute neutrophil count (ANC) < 0.5 × 10^9/L, where ANC is measured the same day or within +/- 1 calendar day of a temperature = 38.0ºC (= 100.4ºF), or
An ANC <0.5 × 10^9/L in combination with:
Documented sepsis or infection, OR
Neutropenia-related hospitalization where ANC is measured the same day or within +/- 1 calendar day.
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Timepoint [5]
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Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)
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Secondary outcome [6]
0
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Percentage of Participants With Grade 3/4 Neutropenia Across the First 4 Cycles of Chemotherapy
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Assessment method [6]
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Grade 3/4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <1.0 x 10^9/L.
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Timepoint [6]
0
0
Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)
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Secondary outcome [7]
0
0
Percentage of Participants With Grade 4 Neutropenia Across the First 4 Cycles of Chemotherapy
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Assessment method [7]
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Grade 4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L.
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Timepoint [7]
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Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)
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Secondary outcome [8]
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Number of Participants With Adverse Events (AEs)
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Assessment method [8]
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A serious adverse event (SAE) is defined as an adverse event that - is fatal; - is life threatening (places the participant at immediate risk of death); - requires inpatient hospitalization or prolongation of existing hospitalization; - results in persistent or significant disability/incapacity; - is a congenital anomaly/birth defect; - other significant medical hazard. AEs were assessed for severity according to National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 3.0, based on this general guideline: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
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Timepoint [8]
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Approximately 8 weeks (4 treatment cycles)
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Eligibility
Key inclusion criteria
Disease-related:
- Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum
- Locally-advanced or metastatic disease by radiographic evaluation
- Measurable disease
- Has not previously received chemotherapy for locally-advanced or metastatic colorectal
cancer. Patient 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.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Demographic:
- Age of 18 years or over
Laboratory:
Adequate organ and marrow function as defined below:
- Absolute neutrophil count at least 1.5 x 10^9/L
- Platelet count at least 100 x 10^9/L
- Bilirubin = 1.5 times upper limit of normal
- Aspartate aminotransferase and alanine aminotransferase = 2.5 x upper limit of normal
or Aspartate aminotransferase and alanine aminotransferase = 5.0 x upper limit of
normal if attributable to liver metastasis
- An in-range international normalized ratio (INR) (in-range is usually defined as
between 2 and 3) for patients on a stable dose of oral anticoagulant or stable dose of
low molecular weight heparin
- 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 upper limit of normal
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
Laboratory:
- Proteinuria > 1+, or total quantitative protein > 500 mg protein/day as determined by
24-hr urine collection
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. Patients 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.
- 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
General:
- 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 participants 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-fluorouracil (5-FU), oxaliplatin, or
leucovorin, including known sensitivity to E. Coli derived products (eg, Filgrastim,
HUMULIN insulin, L-asparaginase)
- Known dihydropyrimidine dehydrogenase deficiency
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/01/2015
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Sample size
Target
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Accrual to date
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Final
847
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Recruitment in Australia
Recruitment state(s)
TAS,VIC
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Recruitment hospital [1]
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Research Site - Hobart
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Recruitment hospital [2]
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Research Site - Ballarat
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Recruitment hospital [3]
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Research Site - Coburg
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Recruitment hospital [4]
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Research Site - Footscray
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Recruitment hospital [5]
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Research Site - Frankston
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Recruitment postcode(s) [1]
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7000 - Hobart
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Recruitment postcode(s) [2]
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3350 - Ballarat
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Recruitment postcode(s) [3]
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3058 - Coburg
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Recruitment postcode(s) [4]
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3011 - Footscray
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Connecticut
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Delaware
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Florida
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Aalst
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Nova Ves pod Plesi
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Olomouc
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Italy
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Taormina (ME)
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Latvia
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Riga
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Mexico
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Colima
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Toluca
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Gdansk
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Romania
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State/province [74]
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Bucharest
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Country [75]
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Romania
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State/province [75]
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Cluj Napoca
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Country [76]
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Romania
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State/province [76]
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Sibiu
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Country [77]
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Russian Federation
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State/province [77]
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Chelyabinsk
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Country [78]
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Russian Federation
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State/province [78]
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Kazan
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Country [79]
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Russian Federation
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State/province [79]
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Moscow
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Country [80]
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Russian Federation
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State/province [80]
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Saint Petersburg
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Country [81]
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Russian Federation
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State/province [81]
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Samara
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Country [82]
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Russian Federation
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State/province [82]
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Yaroslavl
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Country [83]
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Slovakia
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State/province [83]
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Bratislava
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Country [84]
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Slovakia
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State/province [84]
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Kosice
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Country [85]
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Slovakia
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State/province [85]
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Rimavska Sobota
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Country [86]
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Slovakia
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State/province [86]
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Trnava
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Country [87]
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Ukraine
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State/province [87]
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Dnipropetrovsk
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Country [88]
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Ukraine
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State/province [88]
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Donetsk
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Country [89]
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Ukraine
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State/province [89]
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Ivano-Frankivsk
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Country [90]
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Ukraine
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State/province [90]
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Kyiv
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Country [91]
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Ukraine
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State/province [91]
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Lviv
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Country [92]
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Ukraine
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State/province [92]
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Uzhgorod
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Ethics approval
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Summary
Brief summary
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating
the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients
with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line
treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or
5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).
This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either
FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall
response rate in each arm at regular intervals over a maximum of 60 months follow-up.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00911170
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Trial related presentations / publications
Pinter T, Klippel Z, Cesas A, Croitoru A, Decaestecker J, Gibbs P, Hotko Y, Jassem J, Kurteva G, Novotny J, O'Reilly S, Salek T, Reiner M, Morrow PK, Choi MR, Whittaker S, Blanke C. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES). Clin Colorectal Cancer. 2017 Jun;16(2):103-114.e3. doi: 10.1016/j.clcc.2016.08.008. Epub 2016 Sep 7.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00911170
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