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Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
This study is currently recruiting patients.
Sponsored by: | Memorial Sloan-Kettering Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy 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. Chemoprotective drugs such as dexamethasone may protect normal cells from the side effects of chemotherapy. Combining more than one chemotherapy drug and giving them after surgery may kill any remaining tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining adjuvant hepatic arterial infusion with combination chemotherapy in treating patients who have resectable hepatic (liver) metastases from colorectal cancer.
Condition | Treatment or Intervention | Phase |
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Colon Cancer liver metastases Rectal Cancer |
Drug: dexamethasone Drug: floxuridine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: chemoprotection Procedure: chemotherapy Procedure: conventional surgery Procedure: hepatic arterial infusion Procedure: supportive care/therapy Procedure: surgery |
Phase I |
MedlinePlus related topics: Colorectal Cancer; Liver Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Adjuvant Study of Hepatic Arterial Infusion of Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Patients With Resectable Hepatic Metastases Secondary to Colorectal Adenocarcinoma
OBJECTIVES:
OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil.
Patients undergo surgery for resection of the liver and placement of the hepatic artery pump.
Treatment repeats every 36 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity.
Patients are followed every 3 months after the completion of treatment.
PROJECTED ACCRUAL: A total of 2-48 patients will be accrued for this study within 12-16 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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