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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003753 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as floxuridine, dexamethasone, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery.
PURPOSE: Phase II trial to study the effectiveness of irinotecan combined with hepatic arterial infusion with floxuridine and dexamethasone after surgery in treating patients who have liver metastases from colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Drug: dexamethasone Drug: floxuridine Drug: irinotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I-II Study of Hepatic Arterial Therapy Via Pump (Protocol D97-063) With Floxuridine (FUDR) and Dexamethasone (DEX) in Combination With Intravenous Irinotecan as Adjuvant Treatment After Resection of Hepatic Metastases From Colorectal Cancer |
| Study Start Date: | September 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation* study of floxuridine and irinotecan.
Patients undergo hepatic resection and pump placement into the abdomen. About 4 weeks after surgery, patients receive irinotecan IV over 30 minutes on days 1 and 15. Patients also receive floxuridine and dexamethasone intra-arterially via an implanted pump continuously on days 1-14. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or disease progression.
Sequential dose escalation of irinotecan is followed by sequential dose escalation of floxuridine. Cohorts of 3-6 patients receive escalating doses of irinotecan and floxuridine until the maximum tolerated doses (MTDs) are determined. The MTD* (phase II dose) is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
NOTE: *The MTDs of irinotecan and floxuridine have been reached as of 10/15/03; phase I closed to accrual as of 10/15/03
Patients are followed every 3 months for 2 years, every 4 months for 2-4 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 2-24 patients will be accrued for the phase I portion of this study within 1 year (phase I closed to accrual as of 10/15/03). A total of 50 additional patients will be accrued for this study at the phase II dose level.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Nancy E. Kemeny, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000066876, MSKCC-98072, MSKCC-98072A(9), NCI-H99-0024 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003753 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
liver metastases recurrent colon cancer recurrent rectal cancer |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Gastrointestinal Diseases Rectal Neoplasms Hormone Antagonists Colonic Diseases Irinotecan Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Rectal Diseases Hormones Neoplasm Metastasis Dexamethasone acetate Digestive System Neoplasms |
Antineoplastic Agents, Hormonal Floxuridine Rectal Neoplasm Adjuvants, Immunologic Intestinal Diseases Glucocorticoids Intestinal Neoplasms Recurrence Camptothecin Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Peripheral Nervous System Agents Adenocarcinoma Antineoplastic Agents, Phytogenic |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Rectal Diseases Neoplastic Processes |
Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Dexamethasone acetate Digestive System Neoplasms Antineoplastic Agents, Hormonal Floxuridine Gastrointestinal Agents Enzyme Inhibitors Intestinal Diseases Glucocorticoids Intestinal Neoplasms Camptothecin Pharmacologic Actions |
