Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

• 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.

• 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.

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.

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

Eligibility 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Nancy E. Kemeny

Study Chair

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 E. Kemeny	Ph: 212-639-8068

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00059930
Information obtained from ClinicalTrials.gov on February 06, 2012

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