Trial comparing treatments for Metastatic Colorectal Carcinoma
Official title Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
ClinicalTrials.gov ID: NCT05863195
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal carcinoma.
Also referred to as ABP 215, Anti-VEGF.
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 phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Patient must be \>= 18 years of age
- Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).
- Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal...
- NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.
- Patient may have calcified pulmonary nodules, and/or =\< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules...
See the full eligibility criteria
Who can join
- Patient must be \>= 18 years of age
- Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).
- Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes).
- NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.
- Patient may have calcified pulmonary nodules, and/or =\< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =\< 6 mm in maximal axial dimension.
- Patient's primary tumor may be in place
- Patient must have received previous first-line chemotherapy that meets one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14...
- NOTE: First-line chemotherapy may have included any of the following regimens as listed in the National Comprehensive Cancer Network (NCCN) Guidelines: leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin...
- Patient must have measurable disease
- Patients who have disease progression, in the judgement of the treating multidisciplinary team, are not eligible.
- This requirement does not apply to patients who developed new colorectal liver metastases within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer
- Patient must meet the following criteria for technical unresectability:
- A margin-negative resection requires resection of three hepatic veins, both portal veins, or the retrohepatic vena cava OR a resection that leaves less than two adequately perfused and drained segments.
- NOTE: Institutional multidisciplinary review is required to confirm unresectability and rule out radiographically positive extrahepatic disease.
- NOTE: Patients who are deemed technically resectable but simultaneous biologically unresectable are not eligible.
- Patient must undergo multiphase imaging of the chest, abdomen, and pelvis inclusive of CT and/or MRI angiography to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 28 days...
- NOTE: If the patient had remote liver-arterial phase imaging greater than 4 weeks from randomization, then only a single phase (portal venous) intravenous contrasted staging CT and/or MRI of the chest/abdomen/pelvis is...
- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and be clinically fit to undergo surgery as determined by the pre-operative evaluation.
- Patient must not have a liver tumor burden exceeding 70% of total liver volume.
- Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization).
- Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE).
- Patient must not have had prior treatment with HAI/floxuridine (FUDR)
- Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.
- Patient must not have CRLM that could be resected with 2-stage hepatectomy, including associating liver partition and portal vein ligation (ALPPS).
- Patient must not have an active infection, serious or non-healing active wound, ulcer, or bone fracture.
- Patient must not have any serious medical problems which would preclude receiving the protocol treatment or would interfere with the cooperation with the requirements of this trial.
- Patient must not have cirrhosis and/or clinical or radiographic evidence of portal hypertension
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
- All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
- A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a...
- Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study.
- Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to protocol randomization)
- Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 28 days prior to protocol randomization)
- Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol randomization)
- Total Bilirubin =\< 1.5 mg/dL (obtained =\< 28 days prior to protocol randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =\< 3.0 x institutional upper limit of normal (ULN)...
- Creatinine =\ = 50 mL/min calculated by the Cockcroft-Gault method (obtained =\< 28 days prior to protocol randomization)
- Calcium \>= institutional lower limit of normal (LLN)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Aurora, Colorado, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Shiloh, Illinois, United States
- Carmel, Indiana, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
+ 31 more site(s).
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 - 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?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Sun City, Arizona, United States; Aurora, Colorado, United States; Aventura, Florida, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.