Phase 1 Trial With SIR-Spheres and Cetuximab +/- Erlotinib

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01432119
Phase
PHASE1
Status
Withdrawn

Conditions

  • Advanced Cancers

Eligibility Criteria

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

Interventions

  • SIR-Spheres — DEVICE
    100% full dose SIR-Spheres on Day 1 of Cycle 1. SIR-Spheres with yttrium-90 microspheres will be given through a catheter in a vein in the groin.
  • Cetuximab — DRUG
    Starting Dose: 200 mg/m2 by vein weekly. During Cycle 1, patients will receive cetuximab during Weeks 2-4. In Cycles 2 and beyond, patients will receive cetuximab weekly.
  • Erlotinib — DRUG
    Starting dose: 100 mg by mouth daily. Erlotinib will be given starting with Cycle 2 at 100 mg by mouth daily. If tolerated, the dose will be increased to 150 mg by mouth daily in Cycle 3.
  • Break-Through Scan — PROCEDURE
    Nuclear medicine "break-through" scan performed within 29 days before receiving SIR-Spheres. The results of this test will be used to determine if a full or partial dose of SIR-Spheres with yttrium-90 microspheres will be delivered.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of the combination of selective internal radiation (SIR)-Spheres with yttrium-90 attached and cetuximab. Some participants will also take erlotinib with this combination. Yttrium-90 microspheres are designed to treat cancer that has spread to the liver. SIR-Spheres are designed to deliver the radiation directly to the liver. This radiation may cause the tumor cells to die. Cetuximab and erlotinib are drugs that are designed to block the epidermal growth factor receptor (EGFR). EGFR is a protein that helps cancer cells grow. Blocking the EGFR may stop tumors from growing.

Key Dates

First listed
Sep 12, 2011
Start date
Dec 31, 2012
Status verified
Apr 2013
Primary completion
Dec 31, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 SIR-Spheres + Cetuximab
    Arm 1: SIR-Spheres with yttrium-90 attached and cetuximab. SIR-Spheres Day 1 of Cycle 1; Cetuximab start 200 mg/m2 by vein (IV) Weeks 2-4 of Cycle 1, then weekly Cycles 2+. 28-day Cycles. Nuclear medicine "break-through" scan performed within 29 days before receiving SIR-Spheres. The results of this test will be used to determine if a full or partial dose of SIR-Spheres with yttrium-90 microspheres will be delivered.
  • Experimental: Arm 2 SIR-Spheres + Cetuximab + Erlotinib.
    Arm 2: SIR-Spheres with yttrium-90 attached, cetuximab, and erlotinib. Physicians will assign patients to Arm 1 or Arm 2 based on their discretion. SIR-Spheres on Day 1 of Cycle 1; Cetuximab start 200 mg/m2 by vein (IV) Weeks 2-4 of Cycle 1, then weekly Cycles 2+. 28-day Cycles. Erlotinib start 100 mg by mouth daily starting with Cycle 2. 28-day Cycles. Nuclear medicine "break-through" scan performed within 29 days before receiving SIR-Spheres. The results of this test will be used to determine if a full or partial dose of SIR-Spheres with yttrium-90 microspheres will be delivered.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 8 weeks ]

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