Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver (6655)

NCT00023868 | Terminated Phase 3

• 4 other identifiers: CDR0000068871ACRIN-6655U01CA079778U01CA080098
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known if chemoembolization is more effective than standard chemotherapy in treating metastatic cancer. PURPOSE: This phase I trial and randomized phase III trial is studying the effectiveness of chemoembolization in treating patients who have colorectal cancer metastatic to the liver.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

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

Interventions

FOLFIRI regimen DRUG

cisplatin DRUG

doxorubicin hydrochloride DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

mitomycin C DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic colorectal adenocarcinoma * Measurable metastasis to liver at least 1.0 cm * Less than 75% of total liver volume * Known extrahepatic disease limited to lymph nodes and less than 2 cm * No ascites * Ineligible for surgery PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 90,000/mm\^3 * No bleeding diathesis not correctable by standard therapy Hepatic: * Ineligible if all of the following criteria are concurrently present: * High risk of hepatic failure (more than 50% liver involvement by tumor) * Bilirubin greater than 2.0 mg/dL * SGOT greater than 100 U/L * Lactate dehydrogenase greater than 425 U/L * No hepatic encephalopathy * No portal vein occlusion without hepatopedal collateral flow demonstrated by angiography * No portal hypertension with hepatofugal flow Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No evidence of congestive heart failure * No severe peripheral vascular disease that would preclude catheterization Other: * No severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior adjuvant immunotherapy regimen for colon cancer Chemotherapy: * At least 6 months since prior adjuvant chemotherapy and recovered * No more than 1 prior adjuvant chemotherapy regimen for colon cancer * No prior hepatic arterial infusion chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 1 month since prior radiotherapy * No prior hepatic radiotherapy Surgery: * At least 1 month since prior surgery * Prior surgical resection or ablation of liver metastases allowed Other: * No other concurrent therapy

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

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Cisplatin; Doxorubicin; Fluorouracil; Irinotecan; Leucovorin; Mitomycin

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Mitomycins; Indolequinones; Quinones; Azirines; Indoles

Study Officials

• Michael C. Soulen, MD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: June 17, 2003
• Study Start: November 1, 2001
• Primary Completion: September 25, 2002
• Study Completion: September 25, 2002
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

US (9)