Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease
An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 weeks
- Procedures mentioned: Physical exams
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The second melphalan/HDS treatment will be administered 6 weeks after the first treatment with an acceptable delay of up to 2 weeks (8 weeks total) to allow for recovery of melphalan-related toxicity, if needed."
- "Safety will be monitored continuously by documentation of AEs, SAEs, clinical laboratory measurements, vital signs, and physical examination."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for people with colon or rectal cancer that has spread mainly to the liver. It tests high-dose melphalan, a cancer drug given directly into the liver, followed by approved cancer treatment, compared with approved cancer treatment alone. Researchers will check safety, side effects, and how well the treatment works in the liver.
The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone. Participants will: * Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone * Visit clinic at least every two weeks for checkups and tests * Complete scans approximately every two months
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Tests on tissue or cells must confirm the cancer and its spread to the liver. Cancer must cover no more than half of the liver.
- Most of the cancer must be in the liver. Surgery or treatments that destroy tumors in place cannot treat it, or cancer elsewhere makes surgery unable to cure it.
- Liver tumors must be measurable on CT or MRI scans.
- Cancer outside the liver must be limited, with the main threat to life in the liver. Limits include up to 5 lung tumors and/or 5 lymph nodes, each no larger than 2 cm. Single tumors treated fully must show no growth for 6 months.
- Required CT and MRI scans must be done within 28 days before assignment to a study group.
- Cancer must have worsened during or after prior treatments, or you could not tolerate them. These include fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy, anti-VEGF treatment, and/or anti-EGFR treatment if your cancer has no RAS gene change.
- You must be fully active or able to do light work, checked within 14 days before assignment to a study group.
Who can't join
- Moderate or severe liver scarring; high pressure in veins near the liver; clots in the liver or portal veins; or past liver treatment using blocked blood vessels, radiation beads, or chemotherapy through a liver artery.
- Certain heart or lung problems that make anesthesia unsafe, or uncontrolled hormone problems, including diabetes or thyroid disease.
- Bleeding disorders, brain tumors or other brain changes that raise bleeding risk, swollen veins at risk of bleeding, an active stomach ulcer, or recently coughing up blood. You also cannot join if you cannot pause blood thinners.
- Another active cancer, or an invasive cancer treated in the past 2 years, except non-melanoma skin cancer; tumors in the lining of the belly; or large belly masses.
- Use of drugs that weaken the immune system; an active bacterial infection affecting the body; or an active viral infection, including hepatitis B or C. Some hepatitis B test results are allowed if no viral DNA is found.
- Certain allergies to study drugs or their ingredients, heparin, or related antibody products; low blood platelets caused by heparin; or a severe iodine contrast allergy that medicines cannot control. Certain inherited problems digesting or absorbing sugars also exclude you.
- Cancer treatment, radiation, or an experimental drug within 30 days before group assignment, or any past treatment with trifluridine-tipiracil.
- Conditions that prevent bevacizumab use, including uncontrolled high blood pressure, certain abnormal openings or holes in the bowel, a stroke or artery clot in the past year, or a vein clot in the past 30 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Histologically confirmed diagnosis of metastatic colorectal cancer and histologically or cytologically proven CRC metastases that occupy 50% or less of the liver parenchyma. * Patient has liver-dominant metastatic disease. Liver-dominant is defined as the majority of total tumor burden is located in the liver, and the liver lesions are not resectable or treatable with ablation or are associated with extrahepatic disease that makes surgical intervention non-curative. * Disease in the liver must be measurable (per RECIST v.1.1 guidelines) by computed tomography (CT) and/or magnetic resonance imaging (MRI). * If there is evidence of extrahepatic metastatic disease, it is limited, and the life-threatening component of disease is in the liver. Limited extrahepatic disease is defined in this protocol as follows: up to 5 tumor lesions in the lung with longest diameter not greater than 2 cm and/or up to 5 lymph nodes that measure 2 cm or less per lesion; solitary lesions definitively treated with no sign of progression in the last 6 months. * Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization. * Previous treatment and progressed on or following, or intolerant to, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and/or an anti-EGFR therapy if RAS wild-type. * ECOG PS of 0-1 within 14 days prior to randomization. Exclusion Criteria: * Child-Pugh Class B or C cirrhosis or evidence of clinically significant portal hypertension by history, endoscopy, or radiologic studies (large abdominal varices, prior history of varices by endoscopy). * New York Heart Association functional classification II, III or IV or active cardiac condition(s), including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease that create(s) undue risks of undergoing general anesthesia. * History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia. * History of bleeding disorders, presence of brain metastases, or other intracranial abnormalities found on baseline radiologic imaging that would put them at risk for bleeding with anti-coagulation. * Known varices at risk of bleeding, including medium or large esophageal or gastric varices, active peptic ulcer, or history of recent hemoptysis. * Active second malignancy, or has history of recently definitively treated invasive cancer in the past 2 years prior to enrolment with the exception of non-melanoma skin cancer. * Peritoneal lesions or large abdominal masses. * Use of immunosuppressive drugs. * Inability to temporarily stop chronic anti-coagulation therapy. * Active bacterial infections with systemic manifestations. * Active viral infection, including Hepatitis B and Hepatitis C infection. NOTE: Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are allowed exception(s). * Severe allergic reaction to iodine contrast that cannot be controlled by premedication with antihistamines and steroids. * History of or known hypersensitivity to melphalan or the components of the melphalan/HDS system. * History of known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia. * Uncontrolled endocrine disorder including diabetes mellitus, hypothyroidism, or hyperthyroidism. * Received anti-cancer therapy including radiotherapy or investigational agent for any indication ≤ 30 days prior to randomization * Previous treatment with trifluridine-tipiracil. * History of allergic reactions attributed to compounds of similar composition to trifluridine/tipiracil or any of its excipients. * Hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption. * History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients. * History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies. * Contraindications to bevacizumab, including uncontrolled hypertension, history of active fistula or bowel perforation (unless in the setting of a resected primary), history of CVA or arterial thrombotic event in the last 1 year, or history of venous thrombotic event in the last 30 days. * Evidence of hepatic vein or portal vein thrombosis * Prior chemoembolization or radioembolization to the liver or prior hepatic arterial infusion therapy
Study sites (9)
CA
- City of Hope · Duarte, CA 91010More trials in Duarte
- UCLA Hematology/Oncology-Santa Monica · Santa Monica, CA 90404More trials in Santa Monica
FL
- Sylvester Comprehensive Cancer Center, University of Miami Hospital · Miami, FL 33136More trials in Miami
- Moffitt Cancer Center · Tampa, FL 33612More trials in Tampa
IL
- Northwestern University - Feinberg School of Medicine · Chicago, IL 60611More trials in Chicago
KS
- The University of Kansas Clinical Research Center · Overland Park, KS 66210More trials in Overland Park
LA
- Ochsner Clinic Foundation · New Orleans, LA 70121More trials in New Orleans
NC
- University of North Carolina · Chapel Hill, NC 27514More trials in Chapel Hill
UT
- Huntsman Cancer Institute, University of Utah · Salt Lake City, UT 84112More trials in Salt Lake City