Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00544349
First received: October 13, 2007
Last updated: May 14, 2011
Last verified: July 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Biological: cetuximab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy: objective tumor response rate (RECIST criteria) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Duration of response [ Designated as safety issue: No ]
  • Duration and rate of tumor control [ Designated as safety issue: No ]
  • Secondary resectability of hepatic metastases [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Tumor progression rate [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2006
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of this regimen by the measurement of objective response rate (RECIST criteria).

Secondary

  • Determine the toxicity of this regimen.
  • Evaluate the duration of tumor response.
  • Determine the duration and rate of tumor control.
  • Determine the rate of secondary resectability of hepatic metastases.
  • Evaluate progression-free survival
  • Determine rate of progression of the tumor.
  • Determine overall survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Patients also receive oxaliplatin by hepatic arterial infusion over 2 hours. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary cancer of the colon or rectum

    • Isolated hepatic metastases
    • Not amenable to curative resection or requirement for complex and or larger (i.e., > 4 liver segments) liver resection
  • Measurable disease (RECIST criteria)
  • Original tumor must be (or have been) removed

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • WHO performance status 0-1
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times normal
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Transaminases ≤ 5 times normal
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Contraindication or allergy grade 3-4 to any components of the study drugs
  • Peripheral neuropathy
  • Intestinal occlusion or subocclusion or prior inflammatory intestinal disease
  • Severe cardiac disease including any of the following:

    • Symptomatic coronary disease
    • Myocardial infarction in the past 6 months
    • New York Heart Association grade II-IV cardiac insufficiency
    • Severe arrhythmia (even if treated)
  • Active or uncontrolled infection
  • Other concurrent serious disorder
  • Severe uncontrolled medical condition
  • Other malignancy within the past 5 years or concurrently except basal cell skin cancer or carcinoma in situ of the cervix
  • Study impossible due to psychological, geographical, or social reasons
  • Prisoners or patients under guardianship

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • Prior chemotherapy except adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, oxaliplatin, irinotecan hydrochloride, and/or bevacizumab (completed > 6 months ago if oxaliplatin- or irinotecan-based)
  • Prior epidermal growth factor (EGF), monoclonal antibody inhibiting transduction of EGF receptor (EGFR), or any other treatment targeting the EGFR
  • Other concurrent anticancer immunotherapy, chemotherapy, or hormone therapy
  • Participation in another study in the past 30 days
  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: NCT00544349

Locations
France
Hopital Saint Andre
Bordeaux, France, 33075
Centre Regional Francois Baclesse
Caen, France, 14076
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
CHU Pitie-Salpetriere
Paris, France, 75651
Centre Eugene Marquis
Rennes, France, 35062
Hopital Paul Brousse
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Investigator: David Malka, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00544349     History of Changes
Other Study ID Numbers: CDR0000564063, FRE-IGR-CHOICE, IGR-1207, INCA-RECF0449
Study First Received: October 13, 2007
Last Updated: May 14, 2011
Health Authority: United States: Federal Government

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

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
Cetuximab
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014