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S1613: A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 Amplification.

Primary Objective:
a. To evaluate the efficacy of trastuzumab and pertuzumab (TP) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival(PFS) on TP compared to control arm of cetuximab and irinotecan (CETIRI).

Secondary Objectives:
a. To evaluate the overall response rate (ORR), including confirmed complete and
partial response per RECIST 1.1, in the TP and CETIRI treatment arms.
b. To evaluate the overall survival (OS) in the TP and CETIRI treatment arms.
c. To evaluate the safety and toxicity of TP compared to CETIRI.

Additional Objectives:
a. To estimate the rates of PFS, OS, and ORR in patients who crossover to TP after disease progression on CETIRI.
b. To bank images for future retrospective analysis.

Translational Objective:
a. To evaluate if the following are predictive of clinical efficacy (PFS and ORR) for patients receiving TP versus CETIRI:
1. HER-2/CEP17 signal ratio
2. HER-2 gene copy number (GCN)
b. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.

Protocol Number: 071806
Phase: Phase II
Applicable Disease Sites: Colon
Drugs Involved: CETUXIMAB
Principal Investigator: Howard Hochster M.D
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
  • RWJBarnabas Health
    • Newark Beth Israel Medical Center
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.