Study on Panitumumab, Regorafenib, or TAS-102 for Treating Advanced Colorectal Cancer

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03992456

Provider View

This clinical trial is comparing the effectiveness of panitumumab with standard treatments regorafenib or TAS-102 in patients with advanced colorectal cancer that has spread or cannot be surgically removed. The study aims to see if panitumumab can better control the cancer than the usual treatments.

Patient Parameters

Program Overview

This study is testing whether retreatment with panitumumab is more effective than standard treatments regorafenib or TAS-102 for patients with advanced colorectal cancer that has spread or cannot be removed by surgery. Panitumumab may help stop cancer cells from growing and spreading. Regorafenib and TAS-102 are other treatments that work in different ways to control cancer growth. The study will compare how well these treatments work in terms of survival, cancer progression, and quality of life.

Description

The main goal of this study is to compare the overall survival of patients with advanced colorectal cancer who receive panitumumab again versus those who receive standard treatments like TAS-102 or regorafenib. Secondary goals include comparing how long patients live without the cancer getting worse, the response rate to the treatments, and the safety and side effects of the treatments. The study will also look at the quality of life of patients receiving these treatments.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will receive panitumumab through an IV every two weeks. This treatment cycle will repeat every 28 days for up to 24 cycles unless the cancer progresses or side effects become unacceptable.

  • Group B: Patients will take TAS-102 or regorafenib orally, as decided by their doctor. TAS-102 is taken twice daily for five days, followed by a two-day break, and then repeated. Regorafenib is taken once daily for 21 days, followed by a seven-day break. This cycle repeats every 28 days for up to 24 cycles unless the cancer progresses or side effects become unacceptable.

After finishing the study treatment, patients will have follow-up visits 30 days later and then every three months for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Recent blood test (Guardant360) within 90 days before starting the study.
  • At least 90 days since last treatment with anti-EGFR therapy (cetuximab or panitumumab).
  • Age 18 or older.
  • Confirmed diagnosis of metastatic or unresectable colorectal cancer.
  • Cancer must be RAS wild-type and BRAF wild-type based on previous tumor tests.
  • Cancer must have progressed after certain standard treatments.
  • At least one measurable tumor that has not been previously treated with radiation.
  • Life expectancy of at least three months.
  • Good overall health with an ECOG performance status of 0, 1, or 2.
  • Adequate blood counts and organ function based on recent tests.
  • Women of childbearing potential and their partners must use effective contraception during the study and for two months after.
  • Negative pregnancy test for women of childbearing potential.
  • Ability to complete study questionnaires.
  • Willingness to provide tissue and blood samples for research.
  • Willingness to return for follow-up visits and comply with study requirements.

Exclusion Criteria

  • Recent cancer treatment within 21 days before starting the study.
  • Taking blood thinners like warfarin.
  • Certain gene mutations or amplifications detected in recent blood tests.
  • Previous treatment with both TAS-102 and regorafenib.
  • Unable to swallow pills.
  • Serious health conditions that could interfere with the study.
  • Not fully recovered from side effects of previous treatments.
  • Pregnant or breastfeeding women.
  • Known brain metastases unless treated and stable.
  • Recent major surgery or serious injury.
  • History of certain heart conditions or recent heart procedures.
  • Known HIV, hepatitis B or C, or other serious infections.
  • History of lung disease or other untreated cancers.
  • Uncontrolled high blood pressure.
  • Recent bleeding events or active infections.
  • Allergies to study drugs or their components.
  • Substance abuse or other conditions that could affect participation.
  • Use of certain herbal remedies or medications within seven days before starting the study.

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