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Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Washington
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030563
  Purpose

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any remaining tumor cells.

PURPOSE: Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: irinotecan hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: radiofrequency ablation
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma

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

Study Start Date:   May 2001

Detailed Description:

OBJECTIVES:

  • Determine the disease-free survival in patients with hepatic metastases from primary colorectal carcinoma treated with surgical resection with or without radiofrequency ablation followed by irinotecan.
  • Determine the overall survival in patients treated with this regimen.
  • Determine the treatment-related toxicity of this regimen in these patients.
  • Correlate the measurement of molecular markers with clinical outcome in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment with radiofrequency ablation in addition to resection (yes vs no).

Patients undergo surgical resection with or without radiofrequency ablation. Beginning 4-8 weeks after surgery, patients receive irinotecan IV over 90 minutes on day 1. Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary colorectal adenocarcinoma
  • Hepatic metastases that are considered completely resectable

    • No more than 4 metastases by dual phase CT scan OR
  • Hepatic metastases that are not completely resectable but are amenable to complete destruction with resection and radiofrequency ablation

    • More than 4 metastases allowed if all disease can be resected or destroyed in situ with radiofrequency ablation
  • No extrahepatic disease in any location
  • No recurrent or second primary colorectal cancer by colonoscopy within the past year
  • Received prior adjuvant chemotherapy with a fluorouracil-based regimen with the last dose at least 1 month prior to surgery
  • No prior radiofrequency ablation with residual viable intrahepatic disease by CT scan
  • No plans to be treated with radiofrequency ablation alone without surgical resection

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 5 times ULN
  • No Gilbert's disease or other known defect in hepatic conjugation or glucuronidation

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring therapy

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 30 days after study
  • No other malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix
  • No active serious infection
  • No other serious underlying medical condition or severe concurrent disease that would preclude study participation
  • No dementia, significantly altered mental status, or psychiatric illness that would preclude study participation
  • No known hypersensitivity to irinotecan
  • No known infection with HIV or AIDS
  • No uncontrolled diabetes mellitus
  • No history of seizures
  • No drug or alcohol abuse within the past year

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No prior irinotecan

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to more than 30% of bone marrow
  • No prior radiotherapy to the liver
  • At least 3 months since prior radiotherapy to the pelvis or other areas

Surgery:

  • See Disease Characteristics
  • No prior resection of hepatic metastases (wedge biopsy allowed)

Other:

  • No concurrent phenytoin, phenobarbital, or other antiepileptic medication
  • No concurrent enrollment in other investigational drug trials
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030563

Locations
United States, Ohio
Ireland Cancer Center    
      Cleveland, Ohio, United States, 44106-5065
United States, Washington
University of Washington School of Medicine    
      Seattle, Washington, United States, 98195
Canada, Ontario
Princess Margaret Hospital    
      Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)

Investigators
Study Chair:     Kevin G. Billingsley, MD     University of Washington    
  More Information

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

Study ID Numbers:   CDR0000069177, UWASH-1200, CWRU-040106, UWASH-440E-ONC-0020-250, NCI-G01-2045, CWRU-UWMC-1200
First Received:   February 14, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00030563
Health Authority:   United States: Federal Government

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:
Digestive System Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Camptothecin
Recurrence
Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




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