Clinical trial · Interventional
Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
A Phase II Trial Evaluating Multiple Metastasectomy Combined With Hepatic Artery Infusion Of Floxuridine (FUDR) And Dexamethasone (DXM), Alternating With Systemic Oxaliplatin (OXAL) And Capecitabine (CAPCIT) For Colorectal Carcinoma Metastatic To The Liver
NCT00026234CI-TRIAL-00011368completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations and different ways may kill more tumor cells.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
| Liver Metastases | — | UNRESOLVED | — |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| floxuridine | Drug | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy)
- description
- Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity. After completion of the fourth course, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity.
- interventionNames
- Drug: floxuridine
- Drug: dexamethasone
- Drug: oxaliplatin
- Drug: capecitabine
Primary outcomes (2)
- measure
- Toxicity of oxaliplatin as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 2.0
- timeFrame
- Up to 6 months
- measure
- Survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal adenocarcinoma metastatic to the liver * No extrahepatic metastases * Prior complete surgical resection of hepatic metastases (at least 1 lesion) within the past 21-56 days * Negative surgical margins unless surrounding normal liver tissue was ablated during surgery * Radiofrequency ablation may be used as adjunct to surgical resection but not as primary treatment * No prior operative ultrasound during resection of hepatic metastases * Prior complete surgical resection of carcinoma of colon or rectum (must appear completely resectable in case of synchronous lesions) * Performance status - ECOG 0-1 * Absolute neutrophil count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis) * Creatinine no greater than ULN * Creatinine clearance greater than 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Adequate oral nutrition (at least 1,500 calories/day) * Able to withstand major operative procedure * No dehydration * No severe anorexia * No frequent nausea or vomiting * No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ * No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis * No concurrent immunotherapy * No concurrent colony-stimulating factors during the first course of study therapy * No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan * One prior 5-FU-based regimen as neoadjuvant treatment for rectal cancer is allowed * No prior hepatic artery infusion therapy with 5-FU or floxuridine * No prior systemic chemotherapy for metastatic disease * No other concurrent chemotherapy * No concurrent radiotherapy * See Disease Characteristics * No prior or concurrent sorivudine or brivudine
References
Publications (1)
- DERIVEDAlberts SR, Roh MS, Mahoney MR, O'Connell MJ, Nagorney DM, Wagman L, Smyrk TC, Weiland TL, Lai LL, Schwarz RE, Molina R, Dentchev T, Bolton JS. Alternating systemic and hepatic artery infusion therapy for resected liver metastases from colorectal cancer: a North Central Cancer Treatment Group (NCCTG)/ National Surgical Adjuvant Breast and Bowel Project (NSABP) phase II intergroup trial, N9945/CI-66. J Clin Oncol. 2010 Feb 10;28(5):853-8. doi: 10.1200/JCO.2009.24.6728. Epub 2010 Jan 4. PMID 20048179