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
6 other identifiers
interventional
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2001
CompletedStudy Start
First participant enrolled
February 1, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedJuly 16, 2013
June 1, 2013
3.9 years
November 9, 2001
July 15, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Toxicity of oxaliplatin as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 2.0
Up to 6 months
Survival rate
From the date of resection, cryoablation, or radiofrequency ablation to up to 2 years
Secondary Outcomes (4)
Survival time
Time from metastasectomy, cryoablation, or radiofrequency ablation to death due to any cause, assessed up to 3.5 years
Time to recurrence
Time from metastasectomy, cryoablation, or radiofrequency ablation to documentation of disease recurrence, assessed up to 2 years
Time to treatment failure
From the date of metastasectomy, cryoablation, radiofrequency ablation to the date at which the patient is removed from treatment due to recurrence, toxicity, or refusal, assessed up to 3.5 years
Adverse events as assessed by NCI CTC version 2.0
Up to 3.5 years
Study Arms (1)
Treatment (chemotherapy)
EXPERIMENTALPatients 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.
Interventions
Given intra-arterially
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NSABP Foundation Inccollaborator
Study Sites (1)
North Central Cancer Treatment Group
Rochester, Minnesota, 55905, United States
Related Publications (1)
Alberts 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: 20048179DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Alberts
North Central Cancer Treatment Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2001
First Posted
January 27, 2003
Study Start
February 1, 2002
Primary Completion
January 1, 2006
Last Updated
July 16, 2013
Record last verified: 2013-06