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Regorafenib in Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Regorafenib
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal cancer, metastatic colorectal cancer, colorectal adenocarcinoma

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 Subjects permanently withdrawn from study participation will not be allowed to re-enter study.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.

Sites / Locations

  • Mayo Clinic
  • University of Rochester
  • University of North Carolina at Chapel Hill
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regorafenib

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.

Secondary Outcome Measures

Number of Subjects Who Respond to Study Treatment.
Association of Adverse Events With the Comprehensive Geriatric Assessments.
Subject's Quality of Life as Assessed by the Comprehensive Geriatric Assessment Form While Receiving Study Treatment.

Full Information

First Posted
April 9, 2015
Last Updated
August 10, 2022
Sponsor
University of Rochester
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02466009
Brief Title
Regorafenib in Metastatic Colorectal Cancer
Official Title
Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
March 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Colorectal cancer, metastatic colorectal cancer, colorectal adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regorafenib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Regorafenib
Other Intervention Name(s)
Stivarga
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Number of Subjects Who Respond 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.
Title
Association of Adverse Events With the Comprehensive Geriatric Assessments.
Time Frame
From the date of study entry until 30 days after the last dose of study treatment.
Title
Subject's Quality of Life as Assessed by the Comprehensive Geriatric Assessment Form While Receiving Study Treatment.
Time Frame
From the date of study entry until 30 days after the last dose of study treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aram Hezel, M.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28712102
Citation
Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.
Results Reference
derived

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Regorafenib in Metastatic Colorectal Cancer

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