Colorectal Adenocarcinoma Metastatic in the Liver study: Floxuridine
Official title Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis
ClinicalTrials.gov ID: NCT07764497
What this study is testing
What is Floxuridine (FUDR)?
This is an investigational chemotherapy medicine being studied to help shrink liver tumors from colon or rectal cancer so surgery might become possible. It is designed to stop cancer cells from making DNA, which prevents them from growing and dividing.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether giving chemotherapy directly into the liver can help people with colorectal cancer that has spread to the liver become eligible for surgery.
- Who it's for
- You may be able to join if you have colorectal cancer that has spread to your liver and surgery is not currently an option.
- What's involved
- You would receive a special chemo infusion through a tube in the liver artery while also getting regular chemo. You will have visits for the infusion, blood tests, and imaging scans.
- Time commitment
- The study lasts about 6 months, with regular clinic visits and imaging checks during that time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic...
- Physically able to tolerate major partial hepatectomy.
- The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding.
- Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration.
- The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
You likely can't join if
- Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration).
- Patient may not have received prior treatment with FUDR.
- Active infection, ascites, hepatic encephalopathy.
- Active concurrent malignancies, except a patient's potentially resectable colorectal primary.
- Extrahepatic metastases except for resectable or ablatable lung metastasis.
- Patient must not have obstruction of GI or GU tract.
See the full eligibility criteria
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Patients with resectable or ablatable lung metastasis are eligible.
- Physically able to tolerate major partial hepatectomy.
- The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement.
- Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen).
- The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
- Patient's liver metastases must comprise \<70% of the liver parenchyma.
- Female patients of child-bearing age must undergo a pregnancy test and have a negative result.
- A patient must have had prior chemotherapy.
- ECOG PS \< 2.
- Within 14 days of registration: o WBC \>3X10E9/L; ANC ≥ 1.5X10E9/L; Platelet count \>100X10E9/L; INR \< 1.5; HGB ≥ 90 g/L; Estimated creatinine clearance ≥30 ml/min (using Cockcroft and Gault formula)
- Age ≥ 18 years.
- Signed informed consent.
- Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Patients with limited/responding lung metastases on Physician's discretion.
- Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration).
- Patient may not have received prior treatment with FUDR.
- Active infection, ascites, hepatic encephalopathy.
- Active concurrent malignancies, except a patient's potentially resectable colorectal primary.
- Extrahepatic metastases except for resectable or ablatable lung metastasis.
- Patient must not have obstruction of GI or GU tract.
- Female patients who are pregnant or lactating.
- Patients may not be receiving any other investigational agents.
- Patients with history of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded (history of stroke or transient ischemic attack within 6 months prior...
- Serious or non-healing active wound, ulcer, or bone fracture.
- Chronic daily treatment with aspirin (\> 325 mg/d) or nonsteroidal anti- inflammatory medications known to inhibit the platelet function.
- Presence of bleeding diathesis or coagulopathy.
- History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure of \> 150/100 mmHg on medication), unstable angina, New York Heart Association...
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.