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SWOG S1613

Trial Overview

Official Title

Testing combination antibody treatment with Trastuzumab and Pertuzumab for advanced or metastatic colorectal cancer

Study Purpose

To compare any good or bad effects of using a combination of antibodies, Trastuzumab and Pertuzumab, to treating with the usual chemotherapy, Cetuximab and Irinotecan.

Diagnosis

Metastatic or locally advanced and unresectable colorectal cancer.

Eligibility

Must have molecular testing performed which includes KRAS and NRAS gene and exon 15 of BRAF gene.

No prior treatment with either Cetuximab or Panitumumab.

Must have had at least one prior regimen of systemic chemotherapy for metastatic or locally advanced, unresectable disease.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Step 1 Registration:  Her-2 Amplification Screening.  
  • Step 2 Registration:  Randomized to either Arm 1 (Trastuzumab + Pertuzumab) or Arm 2 (Cetuximab + Irinotecan).
  • Step 3 Registration (for Arm 2 patients only):  Optional crossover to Trastuzumab + Pertuzumab.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
S1613
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