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Related Studies
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on May 6, 2003.   Last Updated on July 22, 2009   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00059930
  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 Intervention Phase
Colorectal Cancer
Metastatic Cancer
 Drug: FOLFOX regimen
Drug: dexamethasone
Drug: floxuridine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: conventional surgery
 Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Dexamethasone Floxuridine Fluorouracil Leucovorin Citrovorum factor Dexamethasone acetate Oxaliplatin Doxiproct plus Leucovorin Calcium Dexamethasone Sodium Phosphate Folinic acid calcium salt pentahydrate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: January 2003
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059930

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy E. Kemeny, MD     212-639-8068        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Nancy E. Kemeny, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00059930     History of Changes
Other Study ID Numbers: CDR0000298988, MSKCC-03005
Study First Received: May 6, 2003
Last Updated: July 22, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
liver metastases
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
 adenocarcinoma of the rectum
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
 Pathologic Processes
Liver Diseases
Adjuvants, Immunologic
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Oxaliplatin
Floxuridine
Fluorouracil
BB 1101
Leucovorin
Levoleucovorin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012



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