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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cetuximab — BIOLOGICAL
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pertuzumab — BIOLOGICAL
  Given IV
• Trastuzumab — BIOLOGICAL
  Given IV
• HER-2 testing — DEVICE
  Central testing of HER-2 for eligibility

Study Details

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.

Key Dates

Start date

Nov 27, 2017

Status verified

Jan 2026

Primary completion

Nov 1, 2022

Completion

Jul 1, 2025

Study Design

Enrollment

240 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (pertuzumab, trastuzumab)
  Patients receive pertuzumab 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.
• Experimental: Arm II (cetuximab, irinotecan hydrochloride)
  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 crossover to Arm I.

Primary Outcome Measure

Progression-free Survival(PFS) [ Time Frame: Up to 3 years post randomization ]

Locations (786)

Find similar trials in Anchorage, AK

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