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
NCT03365882 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-02-10
Summary
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.
Conditions
- Colon Adenocarcinoma
- ERBB2 Gene Amplification
- Rectal Adenocarcinoma
- Recurrent Colon Carcinoma
- Recurrent Rectal Carcinoma
- Stage III Colon Cancer AJCC v7
- Stage III Rectal Cancer AJCC v7
- Stage IIIA Colon Cancer AJCC v7
- Stage IIIA Rectal Cancer AJCC v7
- Stage IIIB Colon Cancer AJCC v7
- Stage IIIB Rectal Cancer AJCC v7
- Stage IIIC Colon Cancer AJCC v7
- Stage IIIC Rectal Cancer AJCC v7
- Stage IV Colon Cancer AJCC v7
- Stage IV Rectal Cancer AJCC v7
- Stage IVA Colon Cancer AJCC v7
- Stage IVA Rectal Cancer AJCC v7
- Stage IVB Colon Cancer AJCC v7
- Stage IVB Rectal Cancer AJCC v7
Interventions
- DEVICE
-
HER-2 testing
Central testing of HER-2 for eligibility
- BIOLOGICAL
-
Given IV
- DRUG
-
Irinotecan Hydrochloride
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
SWOG Cancer Research Network
lead NETWORK
Principal Investigators
-
Kanwal Raghav · SWOG Cancer Research Network
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-27
- Primary Completion
- 2022-11-01
- Completion
- 2025-07-01
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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