Metastatic Colorectal Cancer Clinical Trial
Official title:
Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study
NCT number | NCT02466009 |
Other study ID # | 55555 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | March 9, 2022 |
Verified date | August 2022 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 Subjects permanently withdrawn from study participation will not be allowed to re-enter study.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. |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Bayer |
United States,
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. |
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