Study on Combining Radiofrequency Electromagnetic Fields with Fruquintinib for Treating Advanced Colorectal Cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor score: 40
ClinicalTrials ID:NCT07130903
This clinical trial is exploring whether adding radiofrequency electromagnetic fields to the drug Fruquintinib can improve survival and is safe for patients with advanced colorectal cancer that hasn't responded to other treatments.
Patient Parameters
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Program Overview
The aim of this study is to find out if using amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) along with the drug Fruquintinib can help patients with metastatic colorectal cancer live longer and if this combination is safe and tolerable. This trial is for patients whose cancer has not responded to standard treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of metastatic colorectal cancer.
- Have information on specific genetic markers like RAS, BRAF, MSI/MMR, and HER2.
- Have tried and not responded to certain chemotherapy and biological therapies, unless not suitable for them.
- Have a disease that can be measured by scans like CT, MRI, or PET.
- Weigh at least 40 kg (about 88 pounds).
- Be 22 years or older.
- Be able to understand and sign a consent form.
- Have a performance status score of 0 to 2, indicating good general health.
- Have adequate organ and bone marrow function as per specific tests.
- Have an expected lifespan of more than 12 weeks.
- Women of childbearing age must avoid pregnancy, and men must avoid fathering a child during and shortly after treatment.
Exclusion Criteria
- Have uncontrolled high blood pressure.
- Have a history of certain stomach or intestinal issues that could cause bleeding or other complications.
- Have had recent bleeding from the stomach or other areas.
- Have had recent blood clots or strokes unless stable on treatment.
- Have significant heart problems or a history of heart attacks or surgeries.
- Have a prolonged QT interval on an ECG or other heart rhythm issues.
- Are taking medications that affect heart rhythm.
- Have taken certain cancer treatments recently.
- Have had major surgery recently or have unhealed surgical wounds.
- Have unresolved side effects from previous cancer treatments.
- Have a history of drug or alcohol abuse.
- Have poorly controlled HIV or active hepatitis infections.
- Have active infections needing IV antibiotics.
- Have cancer that has spread to major blood vessels or untreated brain metastases.
- Have another active cancer that could interfere with the study.
- Cannot take oral medication or have conditions affecting drug absorption.
- Have metabolic disorders affecting the study drug.
- Have previously taken Fruquintinib or are allergic to it.
- Are taking certain medications that interact with the study drug.
- Are pregnant or breastfeeding.
- Have received a live vaccine recently.
- Cannot comply with study requirements or use the study device.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Karmanos Cancer Institute at McLaren Bay Region | 48706 | Bay City | Michigan |
| Karmanos Cancer Institute at McLaren Clarkston | 48346 | Clarkston | Michigan |
| Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| Karmanos Cancer Institute at McLaren Flint | 48532 | Flint | Michigan |
| Karmanos Cancer Institute at McLaren Greater Lansing | 48910 | Lansing | Michigan |
| Karmanos Cancer Institute at McLaren Lapeer Region | 48446 | Lapeer | Michigan |
| Karmanos Cancer Institute at McLaren Macomb | 48043 | Macomb | Michigan |
| Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey | 49770 | Petoskey | Michigan |
| Karmanos Cancer Institute at McLaren Port Huron | 48060 | Port Huron | Michigan |
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