Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
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, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Unresectable liver metastases secondary to colorectal cancer Less than 70% liver involvement on CT scan or MRI Liver biopsy required before study unless 1 of the following conditions are met: Carcinoembryonic antigen greater than 30 5 or more liver metastases visible on CT scan or MRI Greater than 50% to under 70% liver involvement on CT scan or MRI Histologically proven primary colorectal cancer that is resected or appears resectable on CT scan and physical exam Documentation of previously resected primaries must be based on pathologic results of the resected tumor Histological documentation of synchronous disease must be based on 1 of the following: Biopsy of primary colorectal tumor before study Suspicious lesion on barium enema, colonoscopy, or sigmoidoscopy, and a liver biopsy positive for adenocarcinoma consistent with the primary colorectal tumor Measurable disease Clearly defined liver mass measuring at least 2 cm or at least 3 liver masses on CT scan or MRI No evidence of extrahepatic disease on CT scan and physical exam No portal vein occlusion or ascites PATIENT CHARACTERISTICS: Age: 18 and over Hepatic: Bilirubin no greater than 2 times normal Other: No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer, carcinoma in situ of the cervix, or grade 1 bladder cancer Not pregnant or nursing Fertile patients must use effective contraception Chemotherapy: At least 1 year since prior adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) At least 6 months since prior adjuvant chemotherapy comprising 5-FU with or without LEV No other prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except for nondisease-related conditions, e.g.: Steroids for adrenal failure Insulin for diabetes Intermittent dexamethasone as an antiemetic Radiotherapy: No prior radiotherapy to the liver
Sites / Locations
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Mercy Cancer Center at Mercy Medical Center-Des Moines
- Iowa Lutheran Hospital
- Midlands Cancer Center at Midlands Community Hospital
- MBCCOP - University of New Mexico HSC
- MetroHealth Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Fox Chase Cancer Center
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- Westmead Hospital
- Instituto de Enfermedades Neoplasicas
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I - laparotomy + conventional surgery + chemotherapy
Arm II - conventional surgery + chemotherapy
Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months. Patients are followed every 3 months.
Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months. Patients are followed every 3 months.