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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

Thank you

Trial Information

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


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.

- Arm I: 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.

- Arm II: 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 on both arms 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.

PROJECTED ACCRUAL: Approximately 340 patients (170 per arm) will be accrued for this study
within approximately 4.5 years.

Inclusion 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

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- See Disease Characteristics

- Bilirubin no greater than 2 times normal

Renal:

- Not specified

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

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

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Nancy E. Kemeny, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064553

NCT ID:

NCT00002716

Start Date:

January 1996

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Mercy Cancer Center at Mercy Medical Center-Des MoinesDes Moines, Iowa  50314
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
MetroHealth Medical CenterCleveland, Ohio  44109