Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACOSOG-Z05032 | |||
| CDR0000305857 | Registry Identifier | NCI Physician Data Query |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy such as floxuridine 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 systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (liver metastases resection only vs ablation with or without resection).
Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity.
Patients are followed every 3 months for 2 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| floxuridine + irinotecan | Experimental | Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| floxuridine | Drug |
| ||
| irinotecan hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| time to hepatic recurrence or progression | Up to 2 years |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic colorectal adenocarcinoma
Primary colorectal adenocarcinoma that has been completely resected (R0 disease)
Metastatic disease
No more than 9 liver metastases
All lesions completely resected or completely treated by ablation (with or without resection)
Disease progression after prior systemic irinotecan for metastatic disease allowed
No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection
Must have the entire liver remnant perfused with a single catheter
Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Medically fit to begin chemotherapy between 4 and 8 weeks after surgery
Prior cancer allowed if all of the following criteria are met:
Undergone potentially curative therapy for all prior malignancies
No other malignancy within the past 5 years except the following:
No evidence of recurrence of any prior malignancy
No prior hepatic arterial infusion pump malfunction, malperfusion, or infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Other
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuman Fong, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Central Baptist Hospital |
| Lexington |
| Kentucky |
| 40503-9985 |
| United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7213 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Integris Oncology Services | Oklahoma City | Oklahoma | 73112 | United States |
| University Medical Group | Providence | Rhode Island | 02908-4735 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005467 | Floxuridine |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided