A Study to Determine the Activity of Robatumumab (SCH 717454, MK-7454) in Participants With Relapsed or Recurrent Colorectal Cancer (P04721, MK-7454-003)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Robatumumab; Irinotecan; Cetuximab; Capecitabine; FOLFOX; CAPEOX/XELOX; FOLFIRI
Intervention description: Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX); Capecitabine (CAPE) or Xeloda® (XEL) + oxaliplatin (OX); Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ irinotecan (IRI)
Intervention MeSH terms: Capecitabine; Irinotecan; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anti-IGF-1R

Summary:

      The purpose of this study was to determine the activity of two doses of robatumumab (SCH
      717454, MK-7454) in participants with relapsed or recurrent colorectal cancer.

      The primary study hypothesis was that decreases in Positron Emission Tomography
      (PET)-assessed tumor glucose metabolism (i.e., fluorodeoxyglucose [FDG] standardized uptake
      value [SUV]) following administration of 10 mg/kg robatumumab will exceed those following
      administration of 0.3 mg/kg robatumumab in participants with relapsed or recurrent colorectal
      cancer who had progressed after first-line chemotherapy.

      Investigator choices of standard chemotherapy: irinotecan as a single agent +/- cetuximab OR
      capecitabine as a single agent, OR FOLFOX (leucovorin calcium [folinic acid][FOL] +
      fluorouracil [F] + oxaliplatin [OX]) OR CAPEO(capecitabine [CAPE] or Xeloda® [XEL] +
      oxaliplatin [OX]) OR FOLFIRI (leucovorin calcium [folinic acid][FOL] + fluorouracil [F] +
      irinotecan [IRI]) +/- cetuximab OR cetuximab as a single agent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Older than 18 years of age, of any race, and gender;

          -  Diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that
             has progressed on at least first-line therapy;

          -  Must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan
             performed at some point during their immediate prior treatment or observation in order
             to determine tumor growth rate;

          -  Must have measurable disease on a CT or MRI study, performed during Screening;

          -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2 and a
             minimum life expectancy of ≥4 months;

          -  Must have adequate organ function within 3 weeks prior to treatment assignment

        Exclusion Criteria:

          -  History of another malignancy;

          -  Known treated or untreated leptomeningeal metastasis, or a metastatic central nervous
             system lesion;

          -  Surgery within 3 weeks;

          -  Radiation therapy within 6 weeks;

          -  A history of uncontrolled diabetes mellitus, defined as a hemoglobin A1C of >7.5% in a
             participant with known diabetes mellitus;

          -  A recent myocardial infarction (within the past year); or a participant who at the
             time of Screening presents with unstable or uncontrolled angina, New York Heart
             Association Class III or IV congestive heart failure, uncontrolled hypertension,
             clinically significant cardiac dysrhythmia or clinically significant electrocardiogram
             abnormality;

          -  An active infection;

          -  Has clinically significant hepatitis at Screening, or is hepatitis C antibody
             positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV)
             seropositive.