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| ID | Type | Description | Link |
|---|---|---|---|
| CCCGHS-CHEMO-SIRT |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with internal radiation may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy together with internal radiation works in treating patients with colorectal cancer that has spread to the liver.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive 1 of the following chemotherapy regimens:
Patients also undergo selective internal radiation therapy (SIRT) comprising yttrium Y 90 resin microspheres on day 2 of chemotherapy course 1 (for patients receiving FOLFOX6 or FOLFIRI chemotherapy regimens) or on day 1, 2, 3, 4, or 5 of course 1 (for patients receiving FUDR chemotherapy regimen). SIRT may repeat in week 10 or 12.
In week 18, patients may undergo surgery if down-staging has occurred or they may receive more chemotherapy.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX6 | Experimental | Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continously over 46 hours beginning on day 1. |
|
| FOLFIRI | Experimental | Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. |
|
| FUDR | Experimental | Patients receive floxuridine IV continuously on days 1-14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| floxuridine | Drug | Given IV |
| |
| fluorouracil |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan | ||
| Hepatic toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic efficacy based on time from selective internal radiation therapy (SIRT) to in-liver disease progression | ||
| Therapeutic efficacy based on the proportion of patients who achieve down-staging among all chemo-SIRT treated patients |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colorectal cancer* meeting 1 of the following criteria:
Liver-only or liver-predominant disease with any of the following:
No active CNS metastasis or diffuse peritoneal metastasis
No hepatic metastases from a second malignancy
No predominant extrahepatic disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth L. Pennington, MD | Goshen Health System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cancer Care at Goshen General Hospital | Recruiting | Goshen | Indiana | 46526 | United States |
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| Drug |
Given IV |
|
| irinotecan hydrochloride | Drug | Given IV |
|
| leucovorin calcium | Drug | Given IV |
|
| oxaliplatin | Drug | Given IV |
|
| 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 |
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| ID | Term |
|---|---|
| D005467 | Floxuridine |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| 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 |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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