A Phase 2 interventional study of floxuridine and fluorouracil in Colorectal Cancer and Metastatic Cancer, sponsored by Goshen Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-19.
Sponsored by Goshen Health System · Phase 2, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 20 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Goshen Health System is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Drug: fluorouracil · Drug: leucovorin calcium · Drug: oxaliplatin
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.
Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium
Patients receive floxuridine IV continuously on days 1-14.
Drug: floxuridine
Given IV
Given IV
Given IV
Given IV
Given IV
Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan
Hepatic toxicity
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
This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Goshen Health System