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:
Institut Gustave Roussy
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
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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:
Drug Information available for:
Fluorouracil
Leucovorin Calcium
Oxaliplatin
Levoleucovorin
Cetuximab
U.S. FDA Resources
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) |
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
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
Institut Gustave Roussy
Investigators
| Investigator: | David Malka, MD, PhD | Institut Gustave Roussy |
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 Neoplasms Neoplasms, Second Primary Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
Fluorouracil Oxaliplatin Cetuximab Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex |
ClinicalTrials.gov processed this record on October 17, 2012
