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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: floxuridine
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: November 2005
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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.
Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
Experimental: FUDR
Patients receive floxuridine IV continuously on days 1-14.
Drug: floxuridine
Given IV

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408551

Locations
United States, Indiana
Center for Cancer Care at Goshen General Hospital Recruiting
Goshen, Indiana, United States, 46526
Contact: Clinical Trials Office - Center for Cancer Care at Goshen Gene    574-535-2858      
Sponsors and Collaborators
Goshen Health System
Investigators
Study Chair: Kenneth L. Pennington, MD Goshen Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth Lee Pennington, Center for Cancer Care at Goshen General Hospital
ClinicalTrials.gov Identifier: NCT00408551     History of Changes
Other Study ID Numbers: CDR0000515900, CCCGHS-CHEMO-SIRT
Study First Received: December 6, 2006
Last Updated: December 18, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
liver metastases
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Irinotecan
Fluorouracil
Camptothecin
Floxuridine
Levoleucovorin
Leucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014