Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer

Conditions

• BRAF V600E Negative
• KRAS Gene Mutation Negative
• Locally Advanced Unresectable Colorectal Adenocarcinoma
• Metastatic Colorectal Adenocarcinoma
• NRAS Gene Mutation Negative
• Stage III Colorectal Cancer AJCC v8
• Stage IIIA Colorectal Cancer AJCC v8
• Stage IIIB Colorectal Cancer AJCC v8
• Stage IIIC Colorectal Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cetuximab — BIOLOGICAL
  Given IV
• Irinotecan — DRUG
  Given IV
• Panitumumab — BIOLOGICAL
  Given IV
• Regorafenib — DRUG
  Given PO

Study Details

This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this research study is to compare the effects, good and/or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.

Key Dates

Start date

Mar 3, 2020

Status verified

Sep 2024

Primary completion

Sep 5, 2023

Completion

Mar 31, 2025

Study Design

Enrollment

22 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (regorafenib)
  Patients receive regorafenib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If received as initial treatment, patients who experience disease progression may switch over to the other treatment regimen, per treating physician discretion.
• Experimental: Arm B (cetuximab, panitumumab, irinotecan)
  Patients receive cetuximab or panitumumab IV over 30-90 minutes on days 1 and 15. Patients may also receive irinotecan IV on days 1 and 15 as determined by the study doctor. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If received as initial treatment, patients who experience disease progression may switch over to the other treatment regimen, per treating physician discretion.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 20 months ]

Locations (15)

Find similar trials in Scottsdale, AZ

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