Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Phase 2

• Conditions: Colorectal Cancer; Metastatic Cancer
• Interventions: Drug: fluorouracil; Drug: floxuridine; Drug: leucovorin calcium; Drug: irinotecan hydrochloride; Drug: oxaliplatin

• Registration Number: NCT00408551
• Lead Sponsor: Goshen Health System

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the tumor response, as measured by total tumor mass, carcinoembryonic antigen (CEA) level, measurable tumor volume by CT scan, and metabolic response by positron emission tomography (PET) scan, in patients with colorectal cancer metastatic to the liver undergoing chemotherapy and selective internal radiation therapy (SIRT) comprising yttrium Y 90 resin microspheres.

* Evaluate the hepatic toxicity of this regimen, as measured by ALT, alkaline phosphatase, and bilirubin levels, in these patients.

Secondary

* Evaluate the therapeutic efficacy of this regimen, using time to in-liver disease progression as an end point, in these patients.

* Evaluate the therapeutic efficacy of this regimen, using down-staging to resectability as an end point, in these patients.

OUTLINE: This is a multicenter study.

Patients receive 1 of the following chemotherapy regimens:

* FOLFOX6: 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: 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: Patients receive floxuridine IV continuously on days 1-14. In all chemotherapy regimens, treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-06
• Study First Posted: 2006-12-07
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FOLFOX6	leucovorin calcium	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.
FOLFOX6	oxaliplatin	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	fluorouracil	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.
FOLFIRI	irinotecan hydrochloride	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.
FOLFIRI	leucovorin calcium	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.
FOLFOX6	fluorouracil	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.
FUDR	floxuridine	Patients receive floxuridine IV continuously on days 1-14.

Primary Outcome Measures

Name	Time	Method
Hepatic toxicity
Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Center for Cancer Care at Goshen General Hospital; 🇺🇸 Goshen, Indiana, United States