Clinical trial · Interventional
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver
A Phase II Trial Of Isolated Hepatic Perfusion (IHP) With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with unresectable colorectal cancer that has metastasized to the liver.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| isolated perfusion | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Response
- measure
- Duration of response
Secondary outcomes (4)
- measure
- Patterns of tumor recurrence (liver vs systemic)
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed colorectal cancer
* Metastatic disease limited to the parenchyma of the liver
* Patients with limited sites of extrahepatic disease AND who have dominant life-limiting disease in the liver are considered eligible provided the extrahepatic sites can be treated with local ablative measures (e.g., resection or external beam radiotherapy)
* No other evidence of unresectable extrahepatic disease by radiological studies
* Unresectable hepatic disease defined by \> 3 sites of disease in the liver, bilobar disease, or tumor abutting major vascular or ductal structures making anatomic resection with liver function preservation impossible
* Measurable disease
* Refractory to prior first-line systemic chemotherapy
* Disease progression during or after completion of treatment with an irinotecan- or oxaliplatin-containing regimen for established hepatic metastases
* Treatment failure is defined as disease progression evidenced by tumor growth OR new lesions on imaging modalities OR increasing carcinoembryonic antigen (CEA)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Hematocrit \> 27.0%
* Platelet count \> 100,000/mm\^3
* WBC \> 3,000/mm\^3
Hepatic
* Bilirubin \< 2.0 mg/dL
* PT ≤ 2 seconds of the upper limit of normal
* ALT and AST elevations secondary to metastatic disease allowed
* Chronic active hepatitis B or C allowed provided there is no evidence of cirrhosis on pathology, radiologic studies, or physical exam
* No history of veno-occlusive disease
* No biopsy proven cirrhosis
* No evidence of significant portal hypertension manifested by ascites, esophageal varices on endoscopy, or radiologic studies showing significant collateral vessels around the organs drained by the portal venous system
* No other liver condition that would preclude study therapy
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance \> 60 mL/min
Cardiovascular
* LVEF ≥ 40%
* No ischemic cardiac disease
* No history of congestive heart failure
Pulmonary
* Chronic obstructive pulmonary disease or other chronic pulmonary disease allowed provided pulmonary function test ≥ 50% of predicted
Other
* Not pregnant or nursing
* Negative pregnancy test
* No active infection
* Weight \> 30 kg
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior biologic therapy for the malignancy and recovered
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy for the malignancy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy for the malignancy and recovered
Surgery
* See Disease Characteristics
Other
* No concurrent immunosuppressive drugs
* No concurrent chronic anticoagulation therapyReferences
Publications (0)
Data not yet available