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Regorafenib in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02466009
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Mohamed Tejani, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Regorafenib Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study
Study Start Date : March 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

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 Name: Stivarga




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466009


Contacts
Contact: Mohamed Tejani, MD 585-275-5863 mohamed_tejani@urmc.rochester.edu
Contact: Supriya Mohile, MD 585-275-5863 supriya_mohile@urmc.rochester.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Joleen M Hubbard, M.D.    507-284-8318    Hubbard.Joleen@mayo.edu   
Sub-Investigator: Joleen Hubbard, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Mohamed Tejani, MD         
Sub-Investigator: Supriya Mohile, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Grant R Williams, MD    919-966-0000    Grant.Williams@unchealth.unc.edu   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Efrat Dotan, MD         
Sponsors and Collaborators
University of Rochester
Bayer
Investigators
Principal Investigator: Mohamed Tejani, M.D. University of Rochester

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mohamed Tejani, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT02466009     History of Changes
Other Study ID Numbers: 55555
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by Mohamed Tejani, University of Rochester:
Colorectal cancer
metastatic colorectal cancer
colorectal adenocarcinoma

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases