Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:January 1996
End Date:August 2006

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PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells. It is
not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic
floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin
in treating patients who have unresectable liver metastases from colorectal cancer.

OBJECTIVES:

- Compare the efficacy, toxicity, and cost of hepatic artery infusion of floxuridine,
leucovorin calcium (CF), and dexamethasone vs IV fluorouracil and IV CF after resection
of primary disease in patients with hepatic metastases secondary to colorectal cancer.

- Compare the quality of life of patients treated with these regimens.

- Measure the level of thymidylate synthase present in liver metastases, and correlate
these levels with objective response and survival in patients treated with these
regimens.

- Assess the p53 mutations, and correlate findings with objective response and survival
in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, percentage of liver involvement on CT scan or MRI (less than 30% vs 30% to under
70%), prior chemotherapy (none vs adjuvant chemotherapy comprising fluorouracil (5-FU) and
leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) completed at least 1 year before
study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6
months before study), and synchronous disease (yes vs no). Patients are randomized to 1 of 2
treatment arms.

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
We found this trial at
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Albuquerque, New Mexico 87131
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Cedar Rapids, Iowa 52403
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Des Moines, IA
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1221 Pleasant St
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
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411 Laurel Street
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
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700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
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Green Bay, WI
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Hershey, PA
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Papillion, NE
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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Westmead, New South Wales 2145
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Westmead,
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