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

NCT00408551 | Unknown Phase 2

• 2 other identifiers: CDR0000515900CCCGHS-CHEMO-SIRT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

• Hepatic toxicity

Secondary Outcomes (2)

• 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

Study Arms (3)

FOLFOX6

EXPERIMENTAL

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; Drug: leucovorin calcium; Drug: oxaliplatin

FOLFIRI

EXPERIMENTAL

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; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

FUDR

EXPERIMENTAL

Patients receive floxuridine IV continuously on days 1-14.

Drug: floxuridine

Interventions

floxuridine DRUG

Given IV

FUDR

fluorouracil DRUG

Given IV

FOLFIRI; FOLFOX6

irinotecan hydrochloride DRUG

Given IV

FOLFIRI

leucovorin calcium DRUG

Given IV

FOLFIRI; FOLFOX6

oxaliplatin DRUG

Given IV

FOLFOX6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Goshen Health System: lead

Study Sites (1)

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, 46526, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Floxuridine; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Uracil; Pyrimidinones; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Kenneth L. Pennington, MD

  Goshen Health System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 7, 2006
• Study Start: November 1, 2005
• Primary Completion: June 1, 2009
• Last Updated: December 19, 2013

Record last verified: 2009-06

Locations

US (1)