PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT00819780
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Panitumumab — DRUG
    Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).
  • Bevacizumab — DRUG
    Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).
  • mFOLFOX6 — DRUG
    mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m\^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m\^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m\^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m\^2) via ambulatory pump administered for a period of 46 to 48 hours.

Study Details

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.

Key Dates

First listed
Jan 9, 2009
Start date
Apr 24, 2009
Status verified
Nov 2022
Primary completion
May 30, 2012
Completion
Jul 7, 2016

Study Design

Enrollment
285 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Panitumumab Plus mFOLFOX6
    Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2) and 5-fluorouracil (5-FU) (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
  • Active Comparator: Bevacizumab Plus mFOLFOX6
    Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2), followed by 5-FU (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks. ]

Locations (63)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35205-
Research SiteHuntsvilleAlabama35805-
Research SiteBerkeleyCalifornia94704-
Research SiteBeverly HillsCalifornia90211-
Research SiteBurbankCalifornia91505-
Research SiteFountain ValleyCalifornia92708-
Research SiteLa VerneCalifornia91750-
Research SiteOrangeCalifornia92868-
Research SiteRiversideCalifornia92501-
Research SiteRosevilleCalifornia95661-
Research SiteDenverColorado80218-
Research SiteStamfordConnecticut06902-
Research SiteWaterburyConnecticut06708-
Research SiteBoynton BeachFlorida33435-
Research SiteCoral SpringsFlorida33065-
Research SiteDaytona BeachFlorida32114-
Research SiteHollywoodFlorida33021-
Research SiteLake WorthFlorida33467-
Research SiteAlpharettaGeorgia30005-
Research SiteAugustaGeorgia30901-
Research SiteSavannahGeorgia31405-
Research SitePost FallsIdaho83854-
Research SiteGurneeIllinois60031-
Research SitePeoriaIllinois61615-
Research SiteIndianapolisIndiana46237-
Research SiteOverland ParkKansas66210-
Research SiteWichitaKansas67214-
Research SiteDanvilleKentucky40422-
Research SiteHazardKentucky41701-
Research SitePaducahKentucky42003-
Research SiteBaltimoreMaryland21204-
Research SiteBethesdaMaryland20817-
Research SiteBostonMassachusetts02111-
Research SiteKalamazooMichigan49048-
Research SiteLambertvilleMichigan48144-
Research SiteLansingMichigan48912-
Research SiteMountain LakesNew Jersey07046-
Research SiteSpartaNew Jersey07871-
Research SiteAlbuquerqueNew Mexico87131-
Research SiteBuffaloNew York14215-
Research SiteEast SetauketNew York11733-
Research SiteStaten IslandNew York10301-
Research SiteHuntersvilleNorth Carolina28078-
Research SiteRaleighNorth Carolina27607-
Research SiteAkronOhio44304-
Research SiteColumbusOhio43228-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19106-
Research SiteGreenvilleSouth Carolina29605-
Research SiteMt. PleasantSouth Carolina29464-
Research SiteMemphisTennessee38120-
Research SiteAustinTexas78759-
Research SiteCorpus ChristiTexas78463-
Research SiteDallasTexas75231-
Research SiteRound RockTexas78665-
Research SiteTempleTexas76508-
Research SiteTylerTexas75702-
Research SiteWhite River JunctionVermont05009-
Research SiteChesapeakeVirginia23320-
Research SiteNewport NewsVirginia23601-
Research SiteNewport NewsVirginia23606-
Research SiteSpokaneWashington99218-
Research SiteVancouverWashington98684-

Find similar trials in Birmingham, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Research Site· Birmingham, ALResearch Site· Huntsville, ALResearch Site· Berkeley, CAResearch Site· Beverly Hills, CAResearch Site· Burbank, CAResearch Site· Fountain Valley, CA

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