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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver  Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver
Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver
For Condition: stage 4 colon cancer,Stage 4 rectal cancer,adenocarcinoma of the rectum,recurrent colon cancer,recurrent rectal cancer,adenocarcinoma of the colon,liver metastases
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , American College of Radiology Imaging Network
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. One way to give chemotherapy drugs is by chemoembolization, which kills tumor cells by delivering drugs directly into the tumor and then blocking the blood flow to the tumor. It is not yet known if chemoembolization is more effective than standard chemotherapy in treating metastatic cancer. PURPOSE: Phase I trial and randomized phase III trial to determine the effectiveness of chemoembolization in treating patients who have colorectal cancer metastatic to the liver. For the phase III part of the trial, patients will be randomly assigned to one of two groups. Patients in group one will receive chemotherapy once a week for 4 weeks. Treatment may be repeated every 6 weeks for as long as benefit is shown. Patients in group two will receive chemotherapy as in group one and will undergo chemoembolization on day 36. The chemotherapy may be repeated as in group one. Chemoembolization may be repeated every 6 weeks for up to four courses. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.
Details: OBJECTIVES: I. Determine the survival of patients with liver-dominant metastatic colorectal adenocarcinoma treated with irinotecan, fluorouracil, and leucovorin calcium with or without hepatic chemoembolization. II. Determine response in the liver, time to hepatic tumor progression, and time to extrahepatic tumor progression in patients treated with these regimens. III. Determine 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. PROTOCOL OUTLINE: This is a phase I dose-escalation study followed by a phase III randomized, multicenter study. Phase I: Patients in phase I are sequentially enrolled to 1 of 3 treatment regimens. 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. Approximately 315 patients will be accrued for phase III of this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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: - See Disease Characteristics - At least 1 month since prior surgery - Prior surgical resection or ablation of liver metastases allowed Other: No other concurrent therapy --Patient Characteristics-- Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: - Absolute granulocyte count at least 2,000/mm3 - Platelet count at least 90,000/mm3 - 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 mU/mL *Lactate dehydrogenase greater than 425 mU/mL - No hepatic encephalopathy 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 - No portal vein occlusion without hepatopedal collateral flow demonstrated by angiography - No portal hypertension with hepatofugal flow 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelSoulen, Study Chair, American College of Radiology Imaging Network
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000068871; ACRIN-6655
Study Start Date: November 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023868
Other Liver Metastases Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
3. Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
4. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
5. FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen
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Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver
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