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| Descriptive Information Fields | |||||||||
| Brief Title † | Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver | ||||||||
| Official Title † | 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 | ||||||||
| Brief Summary | RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. 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. Patients are followed every 3 months for 1 year and then every 6 months for 2.5 years. PROJECTED ACCRUAL: A total of 15-75 patients will be accrued for this study within 9 months-3.25 years. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Colorectal Cancer Metastatic Cancer |
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| Intervention † | Drug: capecitabine Drug: dexamethasone Drug: floxuridine Drug: oxaliplatin Procedure: adjuvant therapy |
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| MEDLINE PMIDs | |||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | |||||||||
| Start Date † | February 2002 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00026234 | ||||||||
| Organization ID | CDR0000069011 | ||||||||
| Secondary IDs †† | NCCTG-N9945, NSABP-CI-66 | ||||||||
| Study Sponsor † | North Central Cancer Treatment Group | ||||||||
| Collaborators †† | National Cancer Institute (NCI) National Surgical Adjuvant Breast and Bowel Project (NSABP) |
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| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | August 2004 | ||||||||
| First Received Date † | November 9, 2001 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||