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

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cetuximab
fluorouracil
leucovorin calcium
oxaliplatin
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, recurrent colon cancer, stage IV rectal cancer, recurrent rectal cancer, liver metastases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Saint Andre
  • Centre Regional Francois Baclesse
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • CHU Pitie-Salpetriere
  • Centre Eugene Marquis
  • Hopital Paul Brousse
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Efficacy: objective tumor response rate (RECIST criteria)

Secondary Outcome Measures

Toxicity as assessed by NCI CTCAE v3.0
Duration of response
Duration and rate of tumor control
Secondary resectability of hepatic metastases
Progression-free survival
Overall survival
Tumor progression rate

Full Information

First Posted
October 13, 2007
Last Updated
May 14, 2011
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00544349
Brief Title
Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
stage IV colon cancer, recurrent colon cancer, stage IV rectal cancer, recurrent rectal cancer, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Efficacy: objective tumor response rate (RECIST criteria)
Secondary Outcome Measure Information:
Title
Toxicity as assessed by NCI CTCAE v3.0
Title
Duration of response
Title
Duration and rate of tumor control
Title
Secondary resectability of hepatic metastases
Title
Progression-free survival
Title
Overall survival
Title
Tumor progression rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Malka, MD, PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Facility Information:
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35062
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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