A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01609231
Phase
PHASE2
Status
Terminated

Conditions

  • Rectal Neoplasms

Eligibility Criteria

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

Interventions

  • Dalotuzumab — DRUG
    Dalotuzumab will be administered intravenously after the completion of irinotecan infusion at a dose of 10 mg/kg once weekly.
  • Irinotecan — DRUG
    Irinotecan 180 mg/m\^2 will be administered intravenously once every two weeks either prior to dalotuzumab (Arm A) or after cetuximab (Arm B). Pre-medication at the discretion of the investigator will follow local or country-specific standard of care.
  • Cetuximab — DRUG
    Cetuximab will be administered intravenously prior to irinotecan at an initial dose of 400 mg/m\^2 followed by weekly infusions of 250 mg/m\^2. Pre-medication at the discretion of the investigator will follow local or country-specific standard of care.

Study Details

The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with intravenous (IV) dalotuzumab (MK-0646) + irinotecan therapy relative to participants treated with IV cetuximab + irinotecan. The primary hypothesis is that administration of dalotuzumab in combination with irinotecan to participants with wild-type KRAS metastatic rectal carcinoma with high insulin growth factor (IGF)-1/low IGF-2 expression levels improves progression-free survival compared to patients treated with cetuximab in combination with irinotecan.

Key Dates

Start date
Jul 6, 2012
Status verified
Apr 2020
Primary completion
Dec 9, 2014
Completion
Dec 9, 2014

Study Design

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

Arms

  • Experimental: Arm A: Dalotuzumab + Irinotecan
    Participants receive irinotecan intravenously (IV), 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).
  • Active Comparator: Arm B: Cetuximab + Irinotecan
    Participants receive cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).

Primary Outcome Measure

Assessment of Progression-free Survival (PFS) [ Time Frame: From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years) ]

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