Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

NCT00004142 | Completed Phase 2

• 5 other identifiers: ID98-035P30CA016672MDA-ID-98035NCI-G99-1616CDR0000067373
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiofrequency ablation may be able to shrink or destroy cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy delivered directly into the blood vessels of the liver may prevent new tumors from growing. Combining these therapies may be an effective treatment for colorectal cancer that has spread to the liver. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation followed by chemotherapy delivered directly into the blood vessels of the liver in treating patients who have colorectal cancer that has spread to the liver.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; liver metastases

Outcome Measures

Primary Outcomes (1)

• Patient Tumor Response Rate

  At 1 month

Study Arms (1)

Radiofrequency Ablation + HAI of Floxuridine/5-FU

EXPERIMENTAL

Radiofrequency Ablation Combined With Post-Ablation Hepatic Arterial Infusion (HAI) of Floxuridine Alternating With 5-Fluorouracil (5-FU)

Drug: Floxuridine; Drug: Fluorouracil (5-FU); Procedure: Conventional surgery; Procedure: Radiofrequency ablation

Interventions

Floxuridine DRUG

Part of hepatic arterial chemotherapy on days 1-7. Treatment repeats every 5 weeks for 6 courses.

Radiofrequency Ablation + HAI of Floxuridine/5-FU

Fluorouracil (5-FU) DRUG

Part of hepatic arterial chemotherapy over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses.

Also known as: 5-FU, 5-Fluorouracil, Adrucil, Efudex

Radiofrequency Ablation + HAI of Floxuridine/5-FU

Conventional surgery PROCEDURE

Open laparotomy to identify target tumor in liver using intraoperative ultrasound.

Also known as: open laparotomy

Radiofrequency Ablation + HAI of Floxuridine/5-FU

Radiofrequency ablation PROCEDURE

Radiofrequency tissue ablation over 20 minutes to each tumor.

Radiofrequency Ablation + HAI of Floxuridine/5-FU

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer metastatic to the liver No preoperative or intraoperative evidence of extrahepatic metastasis including clinical, radiographic, gross or microscopic evidence Tumors must be no more than 4 cm in diameter No more than 6 total tumors May have failed prior systemic chemotherapy Failure of 1 prior intra-arterial regimen excluding floxuridine, fluorouracil, or another fluoropyrimidine allowed if liver enzymes recovered No evidence of cirrhosis No gross ascites PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 16 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active duodenal or gastric ulcers Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6-8 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to the liver Surgery: Not specified

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Floxuridine; Fluorouracil; 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)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Uracil; Pyrimidinones; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Lee M. Ellis, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: March 15, 2004
• Study Start: August 5, 1998
• Primary Completion: December 9, 2003
• Study Completion: December 9, 2003
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

US (1)