Study ID: S1613
This trial is for patients who have been diagnosed with locally advanced or metastatic HER2/Neu colorectal cancer and whose tumors cannot be surgically removed.
Participants are grouped into two treatment arms:
- Those in Arm 1 will receive the chemotherapy drug Herceptin (trastuzumab) and pertuzumab, a monoclonal antibody. Both drugs are administered intravenously every 21 days.
- Those in Arm 2 will receive the monoclonal antibody cetuximab and the drug irinotecan hydrochloride. Both medications are administered intravenously every 14 days.
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 study is evaluating the efficacy of trastuzumab and pertuzumab (TP) (Arm 1) in HER-2 amplified mCRC by comparing progression-free survival on TP compared to control arm (Arm 2) of cetuximab and irinotecan hydrochloride (irinotecan).
- 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 cross over to Arm I.
After completion of study treatment, patients are followed for 3 years.
- Must have been diagnosed with locally advanced or metastatic HER2/Neu colorectal cancer
- Must not have undergone surgery for cancer removal
- Must be willing to undergo follow-up care for up to three years