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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00408551
First received: December 6, 2006
Last updated: December 18, 2013
Last verified: June 2009

December 6, 2006
December 18, 2013
November 2005
June 2009   (final data collection date for primary outcome measure)
  • Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan [ Designated as safety issue: No ]
  • Hepatic toxicity [ Designated as safety issue: Yes ]
  • Tumor response as measured by CEA level, RECIST criteria, and PET scan
  • Hepatic toxicity
Complete list of historical versions of study NCT00408551 on ClinicalTrials.gov Archive Site
  • Therapeutic efficacy based on time from selective internal radiation therapy (SIRT) to in-liver disease progression [ Designated as safety issue: No ]
  • Therapeutic efficacy based on the proportion of patients who achieve down-staging among all chemo-SIRT treated patients [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Metastatic Cancer
  • Drug: floxuridine
    Given IV
  • Drug: fluorouracil
    Given IV
  • Drug: irinotecan hydrochloride
    Given IV
  • Drug: leucovorin calcium
    Given IV
  • Drug: oxaliplatin
    Given IV
  • Experimental: 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.
    Interventions:
    • Drug: fluorouracil
    • Drug: leucovorin calcium
    • Drug: oxaliplatin
  • Experimental: 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.
    Interventions:
    • Drug: fluorouracil
    • Drug: irinotecan hydrochloride
    • Drug: leucovorin calcium
  • Experimental: FUDR
    Patients receive floxuridine IV continuously on days 1-14.
    Intervention: Drug: floxuridine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT00408551
CDR0000515900, CCCGHS-CHEMO-SIRT
Not Provided
Kenneth Lee Pennington, Center for Cancer Care at Goshen General Hospital
Goshen Health System
Not Provided
Study Chair: Kenneth L. Pennington, MD Goshen Health System
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP