Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over NCI MSKCC-03005 NCT00059930

Objectives

1. Determine the maximum tolerated dose of intravenous oxaliplatin and fluorouracil when administered with leucovorin calcium in combination with hepatic arterial infusion of floxuridine and dexamethasone in patients with resectable hepatic metastases secondary to colorectal adenocarcinoma.
2. Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and excision repair cross-complementing genes in normal and tumor liver tissue with survival and recurrence in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed colorectal adenocarcinoma metastatic to the liver
  • No clinical or radiographic evidence of extrahepatic disease



• Potentially completely resectable hepatic metastases without current evidence of other metastatic disease



• No ascites

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• At least 3 weeks since prior chemotherapy
• No prior oxaliplatin
• No prior cisplatin
• No prior hepatic arterial infusion of floxuridine

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy to the pelvis
• No prior radiotherapy to the liver

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• No hepatic encephalopathy

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• No active infection

Expected Enrollment

A total of 2-78 patients will be accrued for this study within 12-16 months.

Outcomes

Maximum tolerated dose
Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue

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.

• Hepatic arterial infusion (HAI) therapy: Approximately 4 weeks after surgery, patients receive HAI therapy comprising floxuridine and dexamethasone on day 1.



• Systemic chemotherapy: Patients receive oxaliplatin IV and leucovorin calcium IV over 120 minutes and fluorouracil IV bolus (followed by a 48-hour infusion of fluorouracil) on days 15 and 29.

  Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Nancy Kemeny, MD, Protocol chair		Ph: 212-639-8068; 800-525-2225

U.S.A.
New Jersey
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Nancy Kemeny, MD	Ph:  212-639-8068 800-525-2225
		William Jarnagin, MD	Ph:  212-639-7601 800-525-2225
			Email: jarnagiw@mskcc.org
		Yuman Fong, MD	Ph:  212-639-2016 800-525-2225
			Email: fongy@mskcc.org

Registry Information
Official Title		A Phase I Study Of Hepatic Arterial Infusion With Floxuridine And Dexamethasone In Combination With Intravenous Oxaliplatin Plus 5-Fluorouracil And Leucovorin As Adjuvant Treatment After Resection Of Hepatic Metastases From Colorectal Cancer
Trial Start Date		2003-01-28
Trial Completion Date		2008-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00059930
Date Submitted to PDQ		2003-03-12
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA08748

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