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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 participants.
Verified by National Cancer Institute (NCI), March 2008

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
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: dexamethasone
Drug: floxuridine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: conventional surgery
Phase I

Genetics Home Reference related topics:   Colorectal Cancer  

MedlinePlus related topics:   Cancer   Colorectal Cancer   Surgery  

ChemIDplus related topics:   Dexamethasone   Dexamethasone acetate   Dexamethasone Sodium Phosphate   Doxiproct plus   Leucovorin Calcium   Citrovorum factor   Folinic acid calcium salt pentahydrate   Leucovorin   Floxuridine   Fluorouracil   Oxaliplatin   Calcium gluconate  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

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 2008 (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, 10021
      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

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

Study ID Numbers:   CDR0000298988, MSKCC-03005
First Received:   May 6, 2003
Last Updated:   June 21, 2008
ClinicalTrials.gov Identifier:   NCT00059930
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

Study placed in the following topic categories:
Dexamethasone
Digestive System Neoplasms
Floxuridine
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Oxaliplatin
Fluorouracil
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Dexamethasone acetate
Colorectal Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients
Vitamin B Complex
Antineoplastic Agents, Hormonal
Growth Substances
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 03, 2008




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