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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 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Kenneth L. Pennington, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Goshen Health System

Authority:

Unspecified

Study ID:

CDR0000515900

NCT ID:

NCT00408551

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • liver metastases
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526