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Clinical Trials (PDQ®)

  • First Published: 12/1/2006
  • Last Modified: 8/26/2008

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Clinical Trials (PDQ®)

Phase II Study of Chemotherapy and Selective Internal Radiation Therapy Comprising Yttrium Y 90 Resin Microspheres in Patients With Colorectal Cancer Metastatic to the Liver. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentUnknown18 and overOtherCCCGHS-CHEMO-SIRT
NCT00408551

Objectives

Primary

  1. 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.
  2. Evaluate the hepatic toxicity of this regimen, as measured by ALT, alkaline phosphatase, and bilirubin levels, in these patients.

Secondary

  1. Evaluate the therapeutic efficacy of this regimen, using time to in-liver disease progression as an end point, in these patients.
  2. Evaluate the therapeutic efficacy of this regimen, using down-staging to resectability as an end point, in these patients.

Entry 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

Prior/Concurrent Therapy:

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

Patient Characteristics:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9 g/dL
  • WBC ≥ 1,500/mm3
  • 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

Expected Enrollment

20

A total of 20 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

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

Secondary Outcome(s)

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

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.

Trial Contact Information

Trial Lead Organizations

Center for Cancer Care at Goshen General Hospital

Kenneth Pennington, MD, Protocol chair
Ph: 574-535-2888; 866-711-2888
Email: kpenning@goshenhealth.com

Registry Information
Official Title 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
Trial Start Date 2005-11-12
Trial Completion Date 2009-06-30 (estimated)
Registered in ClinicalTrials.gov NCT00408551
Date Submitted to PDQ 2006-10-19
Information Last Verified 2009-06-28

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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