Regorafenib in Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466009
• Other study ID #: 55555
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: March 9, 2022

Study information

• Verified date: August 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 9, 2022
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.		From the date of study entry until 30 days after the last dose of study treatment.
Secondary	Number of Subjects Who Respond to Study 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.
Secondary	Association of Adverse Events With the Comprehensive Geriatric Assessments.		From the date of study entry until 30 days after the last dose of study treatment.
Secondary	Subject's Quality of Life as Assessed by the Comprehensive Geriatric Assessment Form While Receiving Study Treatment.		From the date of study entry until 30 days after the last dose of study treatment.