Recruiting
Phase 2

Chemotherapy & Radiation

Sponsor:

Goshen Health System

Code:

NCT00408551

Conditions

Colorectal Cancer

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

floxuridine

fluorouracil

irinotecan hydrochloride

leucovorin calcium

oxaliplatin

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Metastatic Cancer

Study ID

NCT00408551

Start date

Nov, 2005

Status verified date

Jun, 2009

Primary completion date

Jun, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

experimental: FUDR

Patients receive floxuridine IV continuously on days 1-14.

Interventions

floxuridine

Given IV

fluorouracil

Given IV

irinotecan hydrochloride

Given IV

leucovorin calcium

Given IV

oxaliplatin

Given IV

Primary outcome measure

  • Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan [ Time Frame: undefined ]
  • Hepatic toxicity [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Center for Cancer Care at Goshen General Hospital

Recruiting

Goshen, Indiana, United States, 46526

Contacts

Clinical Trials Office - Center for Cancer Care at Goshen Gene

574-535-2858

More Information

Sponsor

Goshen Health System

Last update posted

Dec 19, 2013

Last verified

Jun, 2009

Keywords

  • stage IV colon cancer
  • stage IV rectal cancer
  • liver metastases
  • recurrent colon cancer
  • recurrent rectal cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Goshen Health System on 2013-12-19.