FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
Eisai Inc.
Study ID
NCT01133990
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • FOLFIRI — DRUG
    FOLFIRI will be administered as IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m\^2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump. The 5-FU IV bolus (400 mg/m\^2) and CIV infusion (2400 mg/m\^2) over 46 hours is repeated on Days 15 and 16 of each cycle.
  • E7820 — DRUG
    E7820 will be administered orally in tablet form once daily, every day of each 28-day treatment cycle.
  • Bevacizumab — DRUG
    Bevacizumab will be administered at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle.

Study Details

The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.

Key Dates

First listed
May 31, 2010
Start date
Mar 4, 2010
Status verified
Jul 2012
Primary completion
Feb 18, 2011
Completion
Feb 18, 2011

Study Design

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

Arms

  • Active Comparator: FOLFIRI
    The FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 and Day 15 of each 28-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional). The 5-FU IV bolus (400 mg/m2) and CIV infusion (2400 mg/m2) over 46 hours is repeated on Days 15 and 16 of each cycle.
  • Experimental: E7820
    E7820 is administered orally in tablet form once daily, every day of each 28-day treatment cycle. For the Phase Ib portion, the doses will be 40 mg/day, 70 mg/day, and 100 mg/day, and for the Phase II portion, the dose will be the MTD recommended Phase IB dose in combination with FOLFIRI, as determined during the Phase Ib portion of the study.
  • Experimental: FOLFIRI plus Bevacizumab
    Bevacizumab at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle

Primary Outcome Measure

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (each cycle length=28 days) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer Center - MidtownDenverColorado80218-
Summit Medical GroupBerkeley HeightsNew Jersey07922-
Hematology Oncology Associates SJ P.A.Mount HollyNew Jersey08060-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
University of Texas Southwestern Medical CenterDallasTexas75246-
Northwest Medical Specialties, PLLCTacomaWashington98405-

Find similar trials in Denver, CO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Rocky Mountain Cancer Center - Midtown· Denver, COSummit Medical Group· Berkeley Heights, NJHematology Oncology Associates SJ P.A.· Mount Holly, NJUniversity of North Carolina at Chapel Hill· Chapel Hill, NCUniversity of Texas Southwestern Medical Center· Dallas, TXNorthwest Medical Specialties, PLLC· Tacoma, WA

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