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

NCT00030563 | Completed Phase 2

• 6 other identifiers: 18033UWASH-1200CWRU-040106UWASH-440E-ONC-0020-250NCI-G01-2045CWRU-UWMC-1200
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Interventions

irinotecan hydrochloride DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

radiofrequency ablation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Irinotecan; Chemotherapy, Adjuvant; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Kevin G. Billingsley, MD

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of General Surgery, Oncology

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2005
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

CA (1); US (2)