A Study to Determine the Activity of Robatumumab (SCH 717454, MK-7454) in Participants With Relapsed or Recurrent Colorectal Cancer (P04721, MK-7454-003)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00551213
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Robatumumab — BIOLOGICAL
  • Irinotecan — DRUG
  • Cetuximab — BIOLOGICAL
  • Capecitabine — DRUG
  • FOLFOX — DRUG
    Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX)
  • CAPEOX/XELOX — DRUG
    Capecitabine (CAPE) or Xeloda® (XEL) + oxaliplatin (OX)
  • FOLFIRI — DRUG
    Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ irinotecan (IRI)

Study Details

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.

Key Dates

Start date
Nov 21, 2007
Status verified
Jul 2018
Primary completion
Jun 4, 2009
Completion
Jun 4, 2009

Study Design

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

Arms

  • Experimental: Robatumumab→Robatumumab
    Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
  • Active Comparator: Chemotherapy→Robatumumab
    Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.

Primary Outcome Measure

Number of Participants With a >20% Decrease in Positron Emission Tomography (PET)-Assessed Tumor Glucose Metabolism: Fluorodeoxyglucose (FDG) Standardized Uptake Value (SUV) in the Target Lesion [ Time Frame: After the first robatumumab dose in Period 2 (Up to approximately 4 weeks after first robatumumab dose in Period 1) ]

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