Colorectal CancerPhase 2NCT00492999
Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
A Phase 2 study testing dexamethasone, floxuridine and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- dexamethasone, floxuridine and fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2007to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal adenocarcinoma metastatic to the liver
- Previously treated or untreated disease
- No clinical or radiographic evidence of extrahepatic disease
- Primary tumor may be present at study registration provided it is not obstructing the intestinal lumen or is significantly bleeding
- If present, the primary tumor will be resected at the time of pump placement
- Must have inoperable liver metastases confirmed by 2-3 hepatobiliary surgeons and the assigned radiologist
- Liver metastases < 70% of the liver parenchyma
- Inoperable liver metastases is defined by one of the following:
- More than 6 metastases in a single lobe with one lesion ≥ 5 cm
- At least 6 metastases distributed diffusely in both lobes of the liver
- When a margin-negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava
- Requires a resection that leaves < 2 hepatic segments (not including the caudate lobe) behind with adequate arterial or portal inflow, venous outflow, and biliary drainage
- No ascites or hepatic encephalopathy
- No history of primary CNS tumors
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- WBC ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- INR < 1.5
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Physically able to tolerate major partial hepatectomy
- No active infection
- No concurrent active malignancies, except potentially resectable primary colorectal tumor
- No bleeding diathesis or coagulopathy
- No history of serious systemic disease, including any of the following:
- Myocardial infarction within the past 6 months
- Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Unstable symptomatic arrhythmia requiring medication
- Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
- Peripheral vascular disease ≥ grade 2
- No serious or nonhealing active wound, ulcer, or bone fracture
- No history of seizures not well controlled with standard medical therapy
- No stroke or transient ischemic attack within the past 6 months
- No concurrent obstruction of the gastrointestinal or genitourinary tract
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior radiotherapy to the pelvis
- Prior chemotherapy allowed
- No prior radiotherapy, hepatic thermal ablation, or resection (other than biopsy) to the liver
- No prior floxuridine
- No prior hepatic arterial infusion
- No concurrent chronic aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
- No other concurrent investigational agents
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York
About this study
Official title: A Phase II Study of the Rate of Conversion to Complete Resection in Patients With Initially Inoperable Hepatic-Only Metastases From Colorectal Cancer After Treatment With Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy
RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver.
Read the detailed description
OBJECTIVES:
Primary
- Assess the rate of conversion to complete resection in patients with initially unresectable colorectal cancer metastatic to the liver treated with hepatic arterial infusion comprising floxuridine and dexamethasone in combination with systemic irinotecan hydrochloride and either oxaliplatin or leucovorin calcium/fluorouracil.
Secondary
- Evaluate the time to progression in patients treated with this regimen.
- Evaluate disease-free survival of patients treated with this regimen.
- Evaluate overall survival of patients treated with this regimen.
- Determine the response rate (complete, partial, and moderate response) in patients treated with this regimen.
- Evaluate the safety profile and tolerability of this regimen in these patients.
- Assess the expression pattern of the VEGF receptor VEGFR1, VEGFR2, and VEGFR3 and their cognate ligands (i.e., VEGF-A, VEGF-B, VEGF-C, VEGF-D, and P1GF) in patients treated with this regimen.
- Correlate circulating angiogenic markers with tumor resectability, disease progression, and patient survival.
- Procure normal and diseased liver tissue for evaluation of thymidylate synthase, p53 gene, p21, topoisomerase 1, dihydropyrimidine dehydrogenase, and excision repair cross-complementing gene levels.
- Assess the expression pattern of tissue factor (TF) and explore its correlation with the TF receptors PAR-1, PAR-2, TF regulators PTEN, k-ras, b- raf, p53, and outcome.(Closed as of 11/30/10)
- Assess the prognostic and predictive role of preoperative, pretreatment, and during treatment serum TF in regards to outcome (progression-free survival and overall survival) and response to treatment with this regimen and to salvage treatments such as EGFR-inhibitors.(Closed as of 11/30/10)
OUTLINE: This is an open-label, nonrandomized study. Patients are assigned to 1 of 2 treatment groups according to receipt of more than 2 prior courses of oxaliplatin (no vs yes).
- Group 1 (no more than 2 prior courses of oxaliplatin): Patients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Group 2 (more than 2 prior courses of oxaliplatin): Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
In both groups, patients may undergo complete resection of liver metastases after completion of at least 3 courses of therapy.
Some patients undergo blood and tissue collection periodically for correlative and immunological studies. Samples are analyzed for VEGF receptor VEGFR1, VEGFR2, VEGFR3, thymidylate synthase, p53, p21, topoisomerase 1, dihydropyrimidine dehydrogenase, and excision repair cross-complementing gene levels.
After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- dexamethasone, floxuridine, fluorouracil, irinotecan hydrochloride, leucovorin calcium
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Given by hepatic arterial infusion
floxuridineDrug
Given by hepatic arterial infusion
fluorouracilDrug
Given IV
Given IV
Given IV
oxaliplatinDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: dexamethasone; Drug: floxuridine; Drug: irinotecan hydrochloride; Drug: oxaliplatin |
| Group 2 | Experimental | Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: dexamethasone; Drug: floxuridine; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate
Measured: 2 years
Secondary outcomes (4)
Antitumor activity
Measured: 2 years
Response rate
Measured: 2 years
Median time to progression
Measured: 2 years
Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael D'Angelica, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterNancy E. Kemeny, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492999
- Sponsor's protocol ID
- 06-075
- Other IDs
- MSKCC-06075
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2007
- Last updated
- 3 Jun 2026
- Results posted
- No
Publications
Correa-Gallego C, Gavane S, Grewal R, Cercek A, Klimstra DS, Gewirtz AN, Kingham TP, Fong Y, DeMatteo RP, Allen PJ, Jarnagin WR, Kemeny N, D'Angelica MI. Prospective evaluation of 18F-fluorodeoxyglucose positron emission tomography in patients receiving hepatic arterial and systemic chemotherapy for unresectable colorectal liver metastases. HPB (Oxford). 2015 Jul;17(7):644-50. doi: 10.1111/hpb.12421. Epub 2015 May 23.
PubMed 26010778D'Angelica MI, Correa-Gallego C, Paty PB, Cercek A, Gewirtz AN, Chou JF, Capanu M, Kingham TP, Fong Y, DeMatteo RP, Allen PJ, Jarnagin WR, Kemeny N. Phase II trial of hepatic artery infusional and systemic chemotherapy for patients with unresectable hepatic metastases from colorectal cancer: conversion to resection and long-term outcomes. Ann Surg. 2015 Feb;261(2):353-60. doi: 10.1097/SLA.0000000000000614.
PubMed 24646562
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Rate of Conversion to Complete Resection in Patients With Initially Inoperable Hepatic-Only Metastases From Colorectal Cancer After Treatment With Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT00492999
- Acronym / sponsor ID
- 06-075
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2007 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver.
Detailed description
OBJECTIVES:
Primary
- Assess the rate of conversion to complete resection in patients with initially unresectable colorectal cancer metastatic to the liver treated with hepatic arterial infusion comprising floxuridine and dexamethasone in combination with systemic irinotecan hydrochloride and either oxaliplatin or leucovorin calcium/fluorouracil.
Secondary
- Evaluate the time to progression in patients treated with this regimen.
- Evaluate disease-free survival of patients treated with this regimen.
- Evaluate overall survival of patients treated with this regimen.
- Determine the response rate (complete, partial, and moderate response) in patients treated with this regimen.
- Evaluate the safety profile and tolerability of this regimen in these patients.
- Assess the expression pattern of the VEGF receptor VEGFR1, VEGFR2, and VEGFR3 and their cognate ligands (i.e., VEGF-A, VEGF-B, VEGF-C, VEGF-D, and P1GF) in patients treated with this regimen.
- Correlate circulating angiogenic markers with tumor resectability, disease progression, and patient survival.
- Procure normal and diseased liver tissue for evaluation of thymidylate synthase, p53 gene, p21, topoisomerase 1, dihydropyrimidine dehydrogenase, and excision repair cross-complementing gene levels.
- Assess the expression pattern of tissue factor (TF) and explore its correlation with the TF receptors PAR-1, PAR-2, TF regulators PTEN, k-ras, b- raf, p53, and outcome.(Closed as of 11/30/10)
- Assess the prognostic and predictive role of preoperative, pretreatment, and during treatment serum TF in regards to outcome (progression-free survival and overall survival) and response to treatment with this regimen and to salvage treatments such as EGFR-inhibitors.(Closed as of 11/30/10)
OUTLINE: This is an open-label, nonrandomized study. Patients are assigned to 1 of 2 treatment groups according to receipt of more than 2 prior courses of oxaliplatin (no vs yes).
- Group 1 (no more than 2 prior courses of oxaliplatin): Patients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Group 2 (more than 2 prior courses of oxaliplatin): Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
In both groups, patients may undergo complete resection of liver metastases after completion of at least 3 courses of therapy.
Some patients undergo blood and tissue collection periodically for correlative and immunological studies. Samples are analyzed for VEGF receptor VEGFR1, VEGFR2, VEGFR3, thymidylate synthase, p53, p21, topoisomerase 1, dihydropyrimidine dehydrogenase, and excision repair cross-complementing gene levels.
After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: dexamethasone, Drug: floxuridine, Drug: irinotecan hydrochloride, Drug: oxaliplatinPatients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
| Group 2 | Experimental | Drug: dexamethasone, Drug: floxuridine, Drug: fluorouracil, Drug: irinotecan hydrochloride, Drug: leucovorin calciumPatients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasoneGiven by hepatic arterial infusion | Drug | Group 1, Group 2 |
| floxuridineGiven by hepatic arterial infusion | Drug | Group 1, Group 2 |
| fluorouracilGiven IV | Drug | Group 2 |
| irinotecan hydrochlorideGiven IV | Drug | Group 1, Group 2 |
| leucovorin calciumGiven IV | Drug | Group 2 |
| oxaliplatinGiven IV | Drug | Group 1 |
Primary outcome
Resectability rate
Time frame: 2 years
4 secondary outcomes
Antitumor activity
Time frame: 2 years
Response rate
Time frame: 2 years
Median time to progression
Time frame: 2 years
Survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 26010778Correa-Gallego C, Gavane S, Grewal R, Cercek A, Klimstra DS, Gewirtz AN, Kingham TP, Fong Y, DeMatteo RP, Allen PJ, Jarnagin WR, Kemeny N, D'Angelica MI. Prospective evaluation of 18F-fluorodeoxyglucose positron emission tomography in patients receiving hepatic arterial and systemic chemotherapy for unresectable colorectal liver metastases. HPB (Oxford). 2015 Jul;17(7):644-50. doi: 10.1111/hpb.12421. Epub 2015 May 23.
- Derived from this study: PubMed 24646562D'Angelica MI, Correa-Gallego C, Paty PB, Cercek A, Gewirtz AN, Chou JF, Capanu M, Kingham TP, Fong Y, DeMatteo RP, Allen PJ, Jarnagin WR, Kemeny N. Phase II trial of hepatic artery infusional and systemic chemotherapy for patients with unresectable hepatic metastases from colorectal cancer: conversion to resection and long-term outcomes. Ann Surg. 2015 Feb;261(2):353-60. doi: 10.1097/SLA.0000000000000614.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D'Angelica, MD principal investigator
Memorial Sloan Kettering Cancer Center
Nancy E. Kemeny, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexamethasone, floxuridine and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resectability rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492999, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.