A Study of Ramucirumab or Icrucumab in Colorectal Cancer

Last updated: July 15, 2019
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

2

Condition

Rectal Cancer

Colon Cancer

Rectal Disorders

Treatment

N/A

Clinical Study ID

NCT01111604
13942
I4Y-IE-JCDB
CP20-0801
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRIor CAPIRI [capecitabine + irinotecan], with or without bevacizumab)

  • Age ≥ 18 years

  • Life expectancy of ≥ 6 months

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry

  • Agrees to adequate contraception during the study period and for 12 weeks after thelast dose of study medication

  • Provided signed informed consent

Exclusion

Exclusion Criteria:

  • Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable ormetastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy isallowed if the last dose of oxaliplatin was administered > 12 months prior torandomization)

  • Has documented and/or symptomatic brain or leptomeningeal metastases

  • Has an ongoing or active infection, symptomatic or poorly controlled cardiacarrhythmia, psychiatric illness/social situations, or any other serious uncontrolledmedical disorders

  • On chronic non-topical corticosteroid treatment. A participant discontinuing suchtreatment > 3 months prior to randomization is eligible

  • Has uncontrolled or poorly controlled hypertension on a standard regimen ofantihypertensive therapy

  • Has a concurrent active malignancy. A participant with previous history of malignancyis eligible, provided that he/she has been disease free for > 3 years

  • If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG]test) or lactating

  • Has received a prior autologous or allogeneic organ or tissue transplantation

  • Has undergone major surgery within 28 days prior to randomization

  • Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior torandomization

  • Has an elective or planned major surgery to be performed during the course of thetrial

  • Has a history of inflammatory bowel disease requiring pharmacological and/or surgicalintervention in the 12 months prior to randomization

Study Design

Total Participants: 158
Study Start date:
August 01, 2010
Estimated Completion Date:
December 31, 2013

Study Description

The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line therapy.

During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.

Connect with a study center

  • ImClone Investigational Site

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • ImClone Investigational Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • ImClone Investigational Site

    Kelowna, British Columbia V1Y 5L3
    Canada

    Site Not Available

  • ImClone Investigational Site

    Surrey, British Columbia V3V 1Z2
    Canada

    Site Not Available

  • ImClone Investigational Site

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • ImClone Investigational Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • ImClone Investigational Site

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • ImClone Investigational Site

    London, Ontario N6A 4L6
    Canada

    Site Not Available

  • ImClone Investigational Site

    Mississauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • ImClone Investigational Site

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • ImClone Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • ImClone Investigational Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • ImClone Investigational Site

    Windsor, Ontario N8W 2X3
    Canada

    Site Not Available

  • ImClone Investigational Site

    Montreal, Quebec H2W 156
    Canada

    Site Not Available

  • ImClone Investigational Site

    Montréal, Quebec H3G 1A1
    Canada

    Site Not Available

  • ImClone Investigational Site

    Montréal, Quebec H3T 1E2
    Canada

    Site Not Available

  • ImClone Investigational Site

    Hudson, Florida 34667
    United States

    Site Not Available

  • ImClone Investigational Site

    New Port Richey, Florida 34655
    United States

    Site Not Available

  • ImClone Investigational Site

    Crestview Hills, Kentucky 41017
    United States

    Site Not Available

  • ImClone Investigational Site

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • ImClone Investigational Site

    Fairfield, Ohio 45014
    United States

    Site Not Available

  • ImClone Investigational Site

    Columbia, South Carolina 29210
    United States

    Site Not Available

  • ImClone Investigational Site

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • ImClone Investigational Site

    Gallatin, Tennessee 37066
    United States

    Site Not Available

  • ImClone Investigational Site

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • ImClone Investigational Site

    Jackson, Tennessee 38301
    United States

    Site Not Available

  • ImClone Investigational Site

    Lebanon, Tennessee 37087
    United States

    Site Not Available

  • ImClone Investigational Site

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • ImClone Investigational Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • ImClone Investigational Site

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • ImClone Investigational Site

    Tyler, Texas 75701
    United States

    Site Not Available

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