Clinical trial · Interventional
Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
A Phase II Trial Of Toxicity Assessment In Two Cohorts Of Patients (Resection Alone Or Ablation With Or Without Resection Of Hepatic Metastases From Colorectal Cancer) Treated With Adjuvant Hepatic Arterial Infusion (HAI) FUDR Plus Systemic CPT-11
NCT00063960CI-TRIAL-00022900completedPhase 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)
RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery. PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| floxuridine | Drug | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- floxuridine + irinotecan
- description
- Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years.
- interventionNames
- Drug: floxuridine
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 2 years
Secondary outcomes (1)
- measure
- time to hepatic recurrence or progression
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic colorectal adenocarcinoma
* Primary colorectal adenocarcinoma that has been completely resected (R0 disease)
* No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast
* Metastatic disease
* No more than 9 liver metastases
* All lesions completely resected or completely treated by ablation (with or without resection)
* All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava
* All resected lesions must have a negative surgical margin (R0)
* Disease progression after prior systemic irinotecan for metastatic disease allowed
* No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection
* No other prior resection of extrahepatic metastases
* Must have the entire liver remnant perfused with a single catheter
* Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2 mg/dL
* Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN)
* AST and ALT no greater than 2.0 times ULN
* No active hepatitis B or C infection
* No histological evidence of cirrhosis
Renal
* Creatinine no greater than 1.5 times ULN
* Calcium less than 1.3 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile
* Medically fit to begin chemotherapy between 4 and 8 weeks after surgery
* Prior cancer allowed if all of the following criteria are met:
* Undergone potentially curative therapy for all prior malignancies
* No other malignancy within the past 5 years except the following:
* Effectively treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix that has been effectively treated by surgery alone
* Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone
* No evidence of recurrence of any prior malignancy
* No prior hepatic arterial infusion pump malfunction, malperfusion, or infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunologic or biologic therapy
Chemotherapy
* No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection)
* No prior hepatic arterial infusion with fluorouracil or floxuridine
Radiotherapy
* No concurrent adjuvant radiotherapy to the pelvis
* No other concurrent radiotherapy
Other
* No other concurrent systemic therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.