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SWOG S1613

Status:

Recruiting | Phase II

Official Title:

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

Study Purpose:

The purpose of this study is 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.

Interventions:

  • 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.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

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.

Patients 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.

Methodist Health System Trial Code:

SWOG S1613

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!