Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, liver metastases, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colorectal cancer* meeting 1 of the following criteria:
- Metachronous metastasis after resection of Dukes A-C (i.e., stage I-III) primary colon cancer with or without adjuvant chemotherapy
- Metachronous metastasis after resection of primary rectal cancer with neoadjuvant or adjuvant chemotherapy
- Synchronous metastatic liver disease with symptomatic or asymptomatic primary colorectal cancer NOTE: *If the patient has a second malignancy with liver metastasis potential, histologic or cytologic confirmation of the liver lesions may be performed as clinically indicated
Liver-only or liver-predominant disease with any of the following:
- Unresected primary disease
- Limited bone or lung disease
- Potentially resectable nodal disease
- Anastomotic disease
- No active CNS metastasis or diffuse peritoneal metastasis
- No hepatic metastases from a second malignancy
- No predominant extrahepatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- WBC ≥ 1,500/mm^3
- Creatinine ≤ 2 mg/dL
- Bilirubin ≤ 2 mg/dL (without extrahepatic biliary obstruction)
- Albumin > 2 g/dL
- INR < 1.5 (without anticoagulation)
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior external-beam radiotherapy to the liver
- Concurrent targeted therapy agents (e.g., bevacizumab or cetuximab) allowed
Sites / Locations
- Center for Cancer Care at Goshen General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
FOLFOX6
FOLFIRI
FUDR
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continously over 46 hours beginning on day 1.
Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1.
Patients receive floxuridine IV continuously on days 1-14.