PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study

Part of paid clinical trials in Muscle Shoals, Alabama.

Sponsor
Amgen
Study ID
NCT00911170
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pegfilgrastim — DRUG
    Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product.
  • Placebo — DRUG
    Administered as a single subcutaneous injection using a pre-filled syringe.
  • Bevacizumab — BIOLOGICAL
    5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle.
  • Standard Chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jun 1, 2009
Start date
Nov 3, 2009
Status verified
Dec 2017
Primary completion
Sep 17, 2012
Completion
Jan 2, 2015

Study Design

Enrollment
847 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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).

Primary Outcome Measure

Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy [ Time Frame: Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle) ]

Locations (72)

FacilityCityStateZIPSite coordinators
Research SiteMuscle ShoalsAlabama35661-
Research SiteJonesboroArkansas72401-
Research SiteAnaheimCalifornia92801-
Research SiteBeverly HillsCalifornia90211-
Research SiteModestoCalifornia95355-
Research SiteSan DiegoCalifornia92161-
Research SiteGreenwichConnecticut06830-
Research SiteDoverDelaware19901-
Research SiteGainesvilleFlorida32605-
Research SiteLoxahatchee GrovesFlorida33470-
Research SitePort Saint LucieFlorida34952-
Research SiteTamaracFlorida33321-
Research SiteHonoluluHawaii96813-
Research SiteGurneeIllinois60031-
Research SiteMaywoodIllinois60153-
Research SiteQuincyIllinois62301-
Research SiteRockfordIllinois61108-
Research SiteNew AlbanyIndiana47150-
Research SiteSouth BendIndiana46617-
Research SiteCouncil BluffsIowa51503-
Research SiteSioux CityIowa51101-
Research SiteWaterlooIowa50701-
Research SiteWaterlooIowa50702-
Research SiteHutchinsonKansas67502-
Research SiteHazardKentucky41701-
Research SiteLexingtonKentucky40503-
Research SitePaducahKentucky42001-
Research SiteShreveportLouisiana71103-
Research SiteBethesdaMaryland20817-
Research SiteCumberlandMaryland21502-
Research SiteRandallstownMaryland21133-
Research SiteTowsonMaryland21204-
Research SiteBostonMassachusetts02130-
Research SiteBostonMassachusetts02135-
Research SiteJefferson CityMissouri65109-
Research SiteKansas CityMissouri64118-
Research SiteSpringfieldMissouri65807-
Research SiteSt LouisMissouri63136-
Research SiteBillingsMontana59101-
Research SiteGrand IslandNebraska68803-
Research SiteKearneyNebraska68845-
Research SiteOmahaNebraska68131-
Research SitePortsmouthNew Hampshire03801-
Research SiteLittle SilverNew Jersey07739-
Research SiteSomervilleNew Jersey08876-
Research SiteAlbuquerqueNew Mexico87131-
Research SiteLake SuccessNew York11042-
Research SiteNyackNew York10960-
Research SiteAshevilleNorth Carolina28801-
Research SiteHickoryNorth Carolina28602-
Research SiteHigh PointNorth Carolina27262-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteCantonOhio44708-
Research SiteCincinnatiOhio45219-
Research SiteMassillonOhio44646-
Research SiteMiddletownOhio45042-
Research SiteLancasterPennsylvania17605-
Research SiteLanghornePennsylvania19047-
Research SiteReadingPennsylvania19605-
Research SiteUplandPennsylvania19013-
Research SiteWest ReadingPennsylvania19611-
Research SiteWillow GrovePennsylvania19090-
Research SiteHilton Head IslandSouth Carolina29926-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteNashvilleTennessee37203-
Research SiteBryanTexas77802-
Research SiteCorpus ChristiTexas78405-
Research SiteCorpus ChristiTexas78412-
Research SiteAbingdonVirginia24211-
Research SiteLynchburgVirginia24501-
Research SiteKennewickWashington99336-
Research SiteSpokaneWashington99220-

Find similar trials in Muscle Shoals, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Research Site· Muscle Shoals, ALResearch Site· Jonesboro, ARResearch Site· Anaheim, CAResearch Site· Beverly Hills, CAResearch Site· Modesto, CAResearch Site· San Diego, CA

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