# 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** · PHASE2 · COMPLETED · sponsor: **SWOG Cancer Research Network** · enrollment: 240 (actual)

## Conditions studied

- 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

- **BIOLOGICAL:** Cetuximab
- **DRUG:** Irinotecan Hydrochloride
- **OTHER:** Laboratory Biomarker Analysis
- **BIOLOGICAL:** Pertuzumab
- **BIOLOGICAL:** Trastuzumab
- **DEVICE:** HER-2 testing

## Key facts

- **NCT ID:** NCT03365882
- **Lead sponsor:** SWOG Cancer Research Network
- **Sponsor class:** NETWORK
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-11-27
- **Primary completion:** 2022-11-01
- **Final completion:** 2025-07-01
- **Target enrollment:** 240 (ACTUAL)
- **Last updated:** 2026-02-10

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03365882

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03365882, "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". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT03365882. Licensed CC0.

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