Regorafenib in Metastatic Colorectal Cancer

August 8, 2024 updated by: Aram Hezel, University of Rochester

Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study

The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be asked to participate in the study because they are aged 70 or older and require treatment for colorectal cancer that has spread to other parts of the body and has not gotten better with other treatment. Subjects will undergo some initial tests to ensure that they meet all criteria necessary to participate in the study. Once the subject has completed initial testing and meets eligibility criteria, the subject will begin treatment with 120 mg of regorafenib (3 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks). After the first cycle, the doctor will discuss the possibility of increasing the dose to 160 mg (4 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks) based on the subjects health status. During the study, assessments will be performed to monitor the subjects tolerance and response to the treatment. Regorafenib will continue as long as the subject is tolerating the treatment and the subjects colorectal cancer is either responding to treatment or remains stable.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma
  • Measurable metastatic disease.
  • Age +/> 70
  • Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
  • Life expectancy >/= 12 weeks
  • Able to understand and willing to sign written informed consent.
  • Laboratory requirements:
  • Total bili ≤ 1.5 x upper limit or normal
  • Alanine aminotransferase & Asparate aminotransferase ≤ 2.5 x upper limit or normal
  • Serum creatinine ≤ 1.5 x upper limit or normal
  • International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal
  • Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1,500. Blood transfusion to meet the inclusion criteria not be allowed.
  • Glomerular filtration rate ≥ 60 ml/min
  • Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least 3 months after the last dose of study drug.
  • Must be able to swallow and retain oral medications

Exclusion Criteria:

  • Currently receiving other systemic therapy for metastatic colorectal cancer
  • Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
  • Uncontrolled hypertension despite optimal medical management
  • Active or clinically significant cardiac disease.
  • Evidence or history of bleeding diathesis or coagulopathy
  • Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks.
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent
  • History of other active malignancy within past 2 years.
  • Patients with phaeochromocytoma
  • Known history of human immunodeficiency virus infection or current chronic/active hepatitis B or C infection.
  • Ongoing infection > grade 2
  • Symptomatic metastatic brain or meningeal tumors
  • Presence of non-healing wound, non-healing ulcer, or bone fracture
  • Renal failure requiring hemo- or peritoneal dialysis
  • Dehydration ≥ grade 1
  • Patients with seizure disorder requiring medication
  • Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
  • Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea
  • History of organ allograft including corneal transplant
  • Known or suspected allergy or hypersensitivity to the study drug
  • Any malabsorption condition
  • Any condition which makes the subject unsuitable for trial participation
  • Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regorafenib

120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)

Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast.
Drug: Regorafenib
Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Other Names:
  • Stivarga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.
Time Frame: From the date of study entry until 30 days after the last dose of study treatment.
From the date of study entry until 30 days after the last dose of study treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Responded to Study Treatment
Time Frame: From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.
Efficacy outcomes will be response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). A participant's best response will be classified per RECIST (Response evaluation criteria in solid tumors) criteria into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). If a participant's best response was complete response, partial response, or stable disease they were classified as responding to treatment.
From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.
Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument
Time Frame: baseline and week 4
The FACT-C instrument is an 11 question survey that asks general questions about the participants digestive system. The instrument scores range from 0-44 with higher scores indicating digestive problems.
baseline and week 4

Other Outcome Measures

Outcome Measure
Time Frame
Exploratory Outcome Measure: Percentage of Patients Who Had a Correlation Between Adverse Events and Response Rate
Time Frame: week 4
week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Bayer

Investigators

  • Principal Investigator: Aram Hezel, M.D., University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimated)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55555

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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