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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

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
irinotecan hydrochloride
adjuvant therapy
conventional surgery
radiofrequency ablation
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center
  • University of Washington School of Medicine
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
April 13, 2017
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030563
Brief Title
Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
Official Title
A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G. Billingsley, MD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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