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A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


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

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


- 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


- Creatinine no greater than 1.5 times ULN


- No myocardial infarction within the past 6 months

- No congestive heart failure requiring therapy


- 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


Biologic therapy:

- Not specified


- See Disease Characteristics

- No prior irinotecan

Endocrine therapy:

- Not specified


- 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


- See Disease Characteristics

- No prior resection of hepatic metastases (wedge biopsy allowed)


- No concurrent phenytoin, phenobarbital, or other antiepileptic medication

- No concurrent enrollment in other investigational drug trials

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kevin G. Billingsley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

October 2005

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • liver metastases
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Washington School of Medicine Seattle, Washington  98195