Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer

NCT00063960 | Completed Phase 2

• 2 other identifiers: ACOSOG-Z05032CDR0000305857
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery. PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

stage IV colon cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; stage IV rectal cancer; liver metastases

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 2 years

Secondary Outcomes (1)

• time to hepatic recurrence or progression

  Up to 2 years

Study Arms (1)

floxuridine + irinotecan

EXPERIMENTAL

Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years.

Drug: floxuridine; Drug: irinotecan hydrochloride

Interventions

floxuridine DRUG

floxuridine + irinotecan

irinotecan hydrochloride DRUG

floxuridine + irinotecan

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic colorectal adenocarcinoma * Primary colorectal adenocarcinoma that has been completely resected (R0 disease) * No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast * Metastatic disease * No more than 9 liver metastases * All lesions completely resected or completely treated by ablation (with or without resection) * All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava * All resected lesions must have a negative surgical margin (R0) * Disease progression after prior systemic irinotecan for metastatic disease allowed * No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection * No other prior resection of extrahepatic metastases * Must have the entire liver remnant perfused with a single catheter * Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2 mg/dL * Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN) * AST and ALT no greater than 2.0 times ULN * No active hepatitis B or C infection * No histological evidence of cirrhosis Renal * Creatinine no greater than 1.5 times ULN * Calcium less than 1.3 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile * Medically fit to begin chemotherapy between 4 and 8 weeks after surgery * Prior cancer allowed if all of the following criteria are met: * Undergone potentially curative therapy for all prior malignancies * No other malignancy within the past 5 years except the following: * Effectively treated basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix that has been effectively treated by surgery alone * Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone * No evidence of recurrence of any prior malignancy * No prior hepatic arterial infusion pump malfunction, malperfusion, or infection PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunologic or biologic therapy Chemotherapy * No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection) * No prior hepatic arterial infusion with fluorouracil or floxuridine Radiotherapy * No concurrent adjuvant radiotherapy to the pelvis * No other concurrent radiotherapy Other * No other concurrent systemic therapy

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503-9985, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7213, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Integris Oncology Services

Oklahoma City, Oklahoma, 73112, United States

Location

University Medical Group

Providence, Rhode Island, 02908-4735, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Floxuridine; Irinotecan

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; Camptothecin; Alkaloids

Study Officials

• Yuman Fong, MD

  Memorial Sloan Kettering 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: July 8, 2003
• First Posted: July 9, 2003
• Study Start: August 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

US (10)