Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver (6655)
NCT ID: NCT00023868
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
INTERVENTIONAL
2001-11-01
2002-09-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Compare the survival of patients with liver-dominant metastatic colorectal adenocarcinoma treated with irinotecan, fluorouracil, and leucovorin calcium with or without hepatic chemoembolization.
* Compare response in the liver, time to hepatic tumor progression, and time to extrahepatic tumor progression in patients treated with these regimens.
* Compare the possible treatment differences with respect to morbidity, toxic effects of chemoembolization, toxic effects of chemotherapy, and death from cancer-related complications in these patients.
OUTLINE: This is a phase I dose-escalation study followed by a phase III randomized, multicenter study. (Phase I closed as of 10/14/02.)
* Phase I: Patients in phase I are sequentially enrolled to 1 of 3 treatment regimens. (Phase I closed as of 10/14/02.)
* Regimen A: Patients receive irinotecan IV over 60-90 minutes, leucovorin calcium IV, and fluorouracil IV over 10 minutes on days 1, 8, 15, and 22. Patients undergo hepatic embolization with embolic suspension only on day 36.
* Regimen B: Patients receive chemotherapy as in regimen A. Patients undergo hepatic chemoembolization with lower-dose cisplatin, doxorubicin, and mitomycin on day 36.
* Regimen C: Patients receive chemotherapy as in regimen A. Patients undergo hepatic chemoembolization with higher-dose cisplatin, doxorubicin, and mitomycin on day 36.
After 1 week of rest, patients in all regimens receive a second 4-week course of systemic chemotherapy.
Cohorts of 3-10 patients are sequentially enrolled until the maximum tolerated dose (MTD) of chemotherapy and chemoembolization is determined. The MTD is defined as the dose preceding that at which at least 4 of 10 patients experience dose-limiting toxicity.
* Phase III: Patients are stratified according to liver volume involvement (less than 25% vs 25-50% vs more than 50% to less than 75%) and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive irinotecan IV over 60-90 minutes, leucovorin calcium IV, and fluorouracil IV over 10 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks in the absence of disease progression.
* Arm II: Patients receive chemotherapy as in arm I. Patients undergo hepatic chemoembolization with cisplatin, doxorubicin, and mitomycin on day 36. Chemotherapy repeats every 6 weeks in the absence of disease progression. Chemoembolization may repeat every 6 weeks for 2-4 courses as necessary.
Patients in phase III are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for phase I of this study. (Phase I closed to accrual as of 10/14/02.) Approximately 315 patients will be accrued for phase III of this study within 2.5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FOLFIRI regimen
cisplatin
doxorubicin hydrochloride
fluorouracil
irinotecan hydrochloride
leucovorin calcium
mitomycin C
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael C. Soulen, MD
Role: STUDY_CHAIR
Abramson Cancer Center at Penn Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Cancer Center
Tucson, Arizona, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.