Clinical trial NCT00551213
Conditions: Colorectal Cancer
Keywords: anti-IGF-1R
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-11-21; Completion date: 2009-06-04
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
Standard chemotherapy was used as a positive validation arm. Randomization was performed so that there could be no bias in the selection of participants for enrollment into the fixed-sequence arms. Once three chemotherapy-treated participants demonstrated decreases in FDG-PET SUV in the target lesion (i.e., \>20% decrease in SUVmax in the defined target lesion) in the PET/computed tomography (CT) scan performed following Cycle 1 Period 1 treatment, it was concluded that this positive validation arm had accomplished its purpose, and all subsequent participants enrolled in the study were assigned treatment with robatumumab for Period 1. There was no intention to compare the data in either period across participants who received chemotherapy with those who received robatumumab.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Robatumumab intervention 2: Irinotecan intervention 3: Cetuximab intervention 4: Capecitabine intervention 5: FOLFOX intervention 6: CAPEOX/XELOX intervention 7: FOLFIRI
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX) intervention 6: Capecitabine (CAPE) or Xeloda® (XEL) + oxaliplatin (OX) intervention 7: Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ irinotecan (IRI)

Protocol documents: