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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002716 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Drug: dexamethasone Drug: floxuridine Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: conventional surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | 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 |
| Study Start Date: | January 1996 |
OBJECTIVES:
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.
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Unresectable liver metastases secondary to colorectal cancer
Liver biopsy required before study unless 1 of the following conditions are met:
Histologically proven primary colorectal cancer that is resected or appears resectable on CT scan and physical exam
Histological documentation of synchronous disease must be based on 1 of the following:
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal therapy except for nondisease-related conditions, e.g.:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center-Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Nebraska | |
| Midlands Cancer Center at Midlands Community Hospital | |
| Papillion, Nebraska, United States, 68128-4157 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Wisconsin | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54307-3453 | |
| Australia, New South Wales | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Peru | |
| Instituto de Enfermedades Neoplasicas | |
| Lima, Peru, 34 | |
| Puerto Rico | |
| San Juan City Hospital | |
| San Juan, Puerto Rico, 00936-7344 | |
| Study Chair: | Nancy E. Kemeny, MD | Memorial Sloan-Kettering Cancer Center |
| Study Chair: | Elin Ruth Sigurdson, MD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000064553, CALGB-9481, ECOG-C9481 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002716 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
adenocarcinoma of the colon adenocarcinoma of the rectum liver metastases |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Hormone Antagonists Colonic Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Leucovorin Antiemetics Hormones Rectal Diseases Vitamins Neoplasm Metastasis |
Micronutrients Dexamethasone acetate Vitamin B Complex Digestive System Neoplasms Antineoplastic Agents, Hormonal Floxuridine Rectal Neoplasm Adjuvants, Immunologic Trace Elements Folinic Acid Intestinal Diseases Immunosuppressive Agents Glucocorticoids Intestinal Neoplasms Recurrence |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Leucovorin Antiemetics Hormones Rectal Diseases |
Neoplastic Processes Neoplasms by Site Pathologic Processes Vitamins Therapeutic Uses Neoplasm Metastasis Micronutrients Dexamethasone acetate Vitamin B Complex Digestive System Neoplasms Antineoplastic Agents, Hormonal Floxuridine Growth Substances Gastrointestinal Agents Intestinal Diseases |