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| Sponsor: | Beckman Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002842 |
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 and giving drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Drug: floxuridine Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: conventional surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | HEPATIC RESECTION FOLLOWED BY CONCURRENT ADJUVANT PORTAL VEIN INFUSION OF FLUORODEOXYURIDINE AND SYSTEMIC 5-FLUOROURACIL AND FOLINIC ACID FOR METASTATIC COLORECTAL CARCINOMA |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 1994 |
OBJECTIVES:
OUTLINE: Following resection of the liver and all extrahepatic colorectal cancer, patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks.
If biopsy-proven metastatic disease develops, treatment may be stopped at the investigator's discretion. Continuation of regional therapy should be considered for extrahepatic failure. No concurrent radiotherapy is permitted.
Patients are followed every 3 months for 3 years, then every 6 months for survival.
PROJECTED ACCRUAL: It is expected that 50 patients will be entered over approximately 5 years.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Intrahepatic metastases required
No extrahepatic disease unless:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
No second malignancy within 5 years except adequately treated:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Study Chair: | Lucille A. Leong, MD | Beckman Research Institute |
More Information
| Study ID Numbers: | CDR0000065077, CHNMC-IRB-94080, NCI-V96-1031 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002842 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplastic Processes Neoplasms by Site Pathologic Processes Vitamins Therapeutic Uses |
Neoplasm Metastasis Micronutrients Vitamin B Complex Digestive System Neoplasms Floxuridine Growth Substances Adjuvants, Immunologic Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms |
