A Study of Ramucirumab or Icrucumab in Colorectal Cancer
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Ramucirumab; Icrucumab; mFOLFOX-6
Intervention description: 8 mg/kg IV Q2W; 15 mg/kg IV Q2W; Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
Intervention MeSH terms: Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colonic Neoplasms; Rectal Neoplasms; Adenocarcinoma; Antibodies, Monoclonal

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 Criteria:

          -  Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI
             or 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 the
             last dose of study medication

          -  Provided signed informed consent

        Exclusion Criteria:

          -  Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or
             metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is
             allowed if the last dose of oxaliplatin was administered > 12 months prior to
             randomization)

          -  Has documented and/or symptomatic brain or leptomeningeal metastases

          -  Has an ongoing or active infection, symptomatic or poorly controlled cardiac
             arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled
             medical disorders

          -  On chronic non-topical corticosteroid treatment. A participant discontinuing such
             treatment > 3 months prior to randomization is eligible

          -  Has uncontrolled or poorly controlled hypertension on a standard regimen of
             antihypertensive therapy

          -  Has a concurrent active malignancy. A participant with previous history of malignancy
             is 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 to
             randomization

          -  Has an elective or planned major surgery to be performed during the course of the
             trial

          -  Has a history of inflammatory bowel disease requiring pharmacological and/or surgical
             intervention in the 12 months prior to randomization