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Home > "H" Clinical Trials Conditions > Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver  Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
For Condition: liver metastases,Rectal Cancer,Colon Cancer
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI),National Surgical Adjuvant Breast and Bowel Project (NSABP)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations and different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver.
Details: OBJECTIVES: - Determine the safety and toxicity of hepatic arterial infusion with floxuridine and dexamethasone followed by systemic therapy with oxaliplatin and capecitabine in patients with surgically resected liver metastases from primary colorectal carcinoma. - Determine the 2-year survival rate of patients treated with this regimen. - Determine the 2-year recurrence rate and time to recurrence in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity. After completion of the fourth course, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2.5 years. PROJECTED ACCRUAL: A total of 15-75 patients will be accrued for this study within 9 months-3.25 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal adenocarcinoma metastatic to the liver - No extrahepatic metastases - Prior complete surgical resection of hepatic metastases (at least 1 lesion) within the past 21-56 days - Negative surgical margins unless surrounding normal liver tissue was ablated during surgery - Radiofrequency ablation may be used as adjunct to surgical resection but not as primary treatment - No prior operative ultrasound during resection of hepatic metastases - Prior complete surgical resection of carcinoma of colon or rectum (must appear completely resectable in case of synchronous lesions) PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,200/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN - No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis) Renal: - Creatinine no greater than ULN OR - Creatinine clearance greater than 60 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Adequate oral nutrition (at least 1,500 calories/day) - Able to withstand major operative procedure - No dehydration - No severe anorexia - No frequent nausea or vomiting - No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ - No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy - No concurrent colony-stimulating factors during the first course of study therapy Chemotherapy: - No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan - One prior 5-FU-based regimen as neoadjuvant treatment for rectal cancer is allowed - No prior hepatic artery infusion therapy with 5-FU or floxuridine - No prior systemic chemotherapy for metastatic disease - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - No prior or concurrent sorivudine or brivudine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RoySmith, Study Chair, NSABP Adjuvant Therapy Center
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Edward Quebbeman 414-805-5835
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
Additional Information:
Study ID Numbers: CDR0000069011; NSABP-CI-66,NCCTG-N9945
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026234
Other Liver Metastases Studies:
1. Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
2. Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer
3. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
4. Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
5. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
Related Studies:
Other liver metastases Clinical Trials
Other Iowa Clinical Trials
Other Sioux City Clinical Trials
Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
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