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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | City of Hope Medical Center |
| 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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
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
| Responsible Party: | Lucille Leong MD-Principal Investigator, City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00002842 History of Changes |
| Other Study ID Numbers: | 94080, P30CA033572, CHNMC-IRB-94080, NCI-V96-1031, CDR0000065077 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 12, 2011 |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
|
Colorectal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
Adjuvants, Immunologic Floxuridine Fluorouracil Leucovorin Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex |