Trial | NCT00408551  Report issue

Title

Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
A Phase II Multi-Institutional Efficacy and Safety Study of Chemotherapy With Selective Internal Radiation Treatment Using Y-90 Microspheres (CHEMO-SIRT) in Patients With Colorectal Cancer Liver Metastasis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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

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 Started
Nov 30
2005
Primary Completion
Jun 30
2009
Anticipated
Last Update
Dec 19
2013
Estimate

Drug leucovorin calcium

Given IV

Drug oxaliplatin

Given IV

Drug floxuridine

Given IV

Drug fluorouracil

Given IV

Drug irinotecan hydrochloride

Given IV

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.

Criteria 

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed colorectal cancer* meeting 1 of the following criteria:

Metachronous metastasis after resection of Dukes A-C (i.e., stage I-III) primary colon cancer with or without adjuvant chemotherapy
Metachronous metastasis after resection of primary rectal cancer with neoadjuvant or adjuvant chemotherapy
Synchronous metastatic liver disease with symptomatic or asymptomatic primary colorectal cancer NOTE: *If the patient has a second malignancy with liver metastasis potential, histologic or cytologic confirmation of the liver lesions may be performed as clinically indicated

Liver-only or liver-predominant disease with any of the following:

Unresected primary disease
Limited bone or lung disease
Potentially resectable nodal disease
Anastomotic disease
No active CNS metastasis or diffuse peritoneal metastasis
No hepatic metastases from a second malignancy
No predominant extrahepatic disease

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy > 3 months
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL
WBC ≥ 1,500/mm^3
Creatinine ≤ 2 mg/dL
Bilirubin ≤ 2 mg/dL (without extrahepatic biliary obstruction)
Albumin > 2 g/dL
INR < 1.5 (without anticoagulation)
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior external-beam radiotherapy to the liver
Concurrent targeted therapy agents (e.g., bevacizumab or cetuximab) allowed
No Results Posted