A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
AVEO Pharmaceuticals, Inc.
Study ID
NCT01478594
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tivozanib — DRUG
    Capsules for oral administration
  • Bevacizumab — DRUG
    Solution for intravenous infusion
  • mFOLFOX6 — DRUG
    mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, leucovorin calcium 400 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, fluorouracil 400 mg/m\^2 administered as an intravenous bolus over 5 to 15 minutes on Days 1 and 15, then 2400 mg/m\^2 continuous intravenous infusion over 46 hours on Days 1 to 3 and 15 to 17.

Study Details

The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6.

Key Dates

First listed
Nov 23, 2011
Start date
Dec 31, 2011
Status verified
Jun 2015
Primary completion
Sep 30, 2013
Completion
Jan 31, 2015

Study Design

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

Arms

  • Experimental: Tivozanib + mFOLFOX6
    Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
  • Active Comparator: Bevacizumab + mFOLFOX6
    Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.

Primary Outcome Measure

Investigator-assessed Progression-Free Survival (PFS) [ Time Frame: From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group. ]

Locations (27)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Research CenterGilbertArizona85234-
Genesis Cancer CenterHot SpringsArizona71913-
Arizona Clinical Research CenterTucsonArizona85715-
University of California San Diego-Morris Cancer CenterLa JollaCalifornia92093-
UC Irvine Medical Center, Division of Hematology/OncologyOrangeCalifornia92868-
Desert Hematology Oncology Medical Group, Inc.Rancho MirageCalifornia92270-
Mountain Blue Cancer Care CenterGoldenColorado80033-
University of Florida, Davis Cancer Center (VA)GainesvilleFlorida32610-
Cleveland Clinic FloridaWestonFlorida33331-
Kaiser Foundation HospitalsHonoluluHawaii96819-
Queen's Medical CenterHonoluluHawaii96813-
University of HawaiiHonoluluHawaii96813-
Northwestern UniversityChicagoIllinois60611-
Illinios Cancer CarePeoriaIllinois61615-
Investigative Clinical Research of Indiana, LLCIndianapolisIndiana46260-
Horizon Oncology Research, Inc.LafayetteIndiana47905-
Associates of Oncology Hematology, P.C.RockvilleMaryland20850-
University of Michigan HealthAnn ArborMichigan48109-
NYU Cancer InstituteNew YorkNew York10016-
Alamance Regional Medical CenterBurlingtonNorth Carolina27215-
Tri Country Hematology / OncologyCantonOhio44718-
Signal Point Clinical Research Center, LLCMiddletownOhio45042-
Cancer Care AssociatesTulsaOklahoma74136-
Oregon Health and Science UniversityPortlandOregon97239-
Oncology Hematology of Lehigh ValleyBethlehemPennsylvania18015-
Northern Utah AssociatesOgdenUtah84403-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Gilbert, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Banner MD Anderson Cancer Research Center· Gilbert, AZGenesis Cancer Center· Hot Springs, AZArizona Clinical Research Center· Tucson, AZUniversity of California San Diego-Morris Cancer Center· La Jolla, CAUC Irvine Medical Center, Division of Hematology/Oncology· Orange, CADesert Hematology Oncology Medical Group, Inc.· Rancho Mirage, CA

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