S1613 Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery
This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to
cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified
colorectal cancer that has spread from where it started to other places in the body and
cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may
interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,
such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of
tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them
from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and
irinotecan hydrochloride in treating patients with colorectal cancer.
I. To evaluate the efficacy of trastuzumab and pertuzumab (TP) (Arm 1) in HER-2 amplified
metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP
compared to control arm (Arm 2) of cetuximab and irinotecan hydrochloride (irinotecan)
I. To evaluate the overall response rate (ORR), including confirmed complete and partial
response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, in treatment Arms 1
II. To evaluate the overall survival (OS) in treatment Arms 1 and 2. III. To evaluate the
safety and toxicity of TP compared to CETIRI.
I. To estimate the rates of PFS, OS, and ORR in patients who crossover to TP (Arm 3) after
disease progression on CETIRI.
II. To bank images for future retrospective analysis. III. To evaluate if HER-2/centromeric
probe (CEP17) signal ratio and HER-2 gene copy number (GCN) are predictive of clinical
efficacy for patients receiving TP versus CETIRI.
IV. To bank tissue and blood samples for other future correlative studies from patients
enrolled on the study.
OUTLINE: Patients with HER2 gene amplification are randomized to 1 of 2 arms.
ARM I: Patients receive pertuzumab intravenously (IV) over 30-60 minutes and trastuzumab IV
over 30-120 minutes on day 1. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
ARM II: Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV
over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression
or unacceptable toxicity. Patients with documented disease progression may optionally
crossover to Arm I.
After completion of study treatment, patients are followed up for 3 years.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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