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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00852228 |
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Date of registration:
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25/02/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Optimal Control of Liver Metastases From Colorectal Cancer With Cetuximab and Hepatic Artery Infusion of Chemotherapy
OPTILIV |
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Scientific title:
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Optimal Control of Liver Metastases With Intravenous Cetuximab and Hepatic Artery Infusion of Three-drug Chemotherapy in Patients With Liver-only Metastases From Colorectal Cancer. A European Multicenter Phase II Trial |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00852228 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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France
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Italy
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Portugal
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Contacts
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Name:
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Francis A. Lévi, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Paul Brousse Hospital, Villejuif, France |
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Key inclusion & exclusion criteria
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- Histologically or cytologically confirmed carcinoma of the colon and/or rectum with
evidence of liver metastases (new confirmation of metastatic disease is required in
case the time interval from last histological diagnosis to enrolment exceeds 3
years).
- Patient with wild type (WT) KRAS tumor status
- Patient whose liver metastases are considered to be non resectable with curative
intent in medico-surgical staff meeting. In particular patients with at least one of
the following criteria, which prevent complete local treatment of liver metastasis
with surgery alone or surgery plus radiofrequency ablation because:
- less than 30% estimated residual liver after resection
- disease in contact with liver main vessels
- documented progressive disease on imaging documents or doubling of serum levels
of carcino-embryonic antigen (CEA) or CA19.9 over the past 90 days or less
- Patient with up to three resectable extrahepatic nodules of <= 10 mm
- One, two or three prior chemotherapy lines for colorectal cancer.
- Written informed consent.
- Age >=18 years.
- Patient must be able to comply with the protocol.
- Life expectancy of at least 3 months.
- At least one measurable metastatic liver lesion (as per RECIST criteria).
- World Health Organization performance status of 0 or 1.
- Adequate hematological function: absolute neutrophil count (ANC) >=1.0 x 10^9/L;
platelets >=75 x 10^9/L, hemoglobin (Hb) >=8.5 g/dL.
- International normalized ratio (INR) <=1.5 and activated partial thromboplastin time
(aPTT) <=1.5 x upper limit of normal (ULN) within 7 days prior to starting study
treatment, in the absence of anticoagulant therapy.
- Liver function: serum bilirubin <=1.5 x ULN; alkaline phosphatase and transaminases
<5 x ULN (liver metastases).
- Serum creatinine <= 1.5 x ULN.
- Fertile women and men of childbearing potential (<2 years after last menstruation in
women) must use effective means of contraception (oral contraceptives, intrauterine
contraceptive device, barrier method of contraception in conjunction with spermicidal
jelly or surgically sterile).
Exclusion Criteria:
- Patient whose primary tumor or metastasis displays mutation of K-Ras (codon 12 and/or
13).
- Unresectable extrahepatic diseases.
- More than three resectable extrahepatic nodules.
- Size of extra hepatic nodules > 1 cm
- Prior HAI of the 3 drugs.
- More than 2 prior surgical attempts for metastatic disease
- Prior radiotherapy for metastatic disease
- Known documented intolerance or hypersensitivity to any of the drugs used.
- Sensory neuropathy grade 3 (National Cancer Institute-Common Terminology Criteria for
Adverse Events -NCI-CTCAE, Version 3.0).
- Past or current history (within the last 2 years prior to treatment start) of
malignancy other than colorectal cancer (patients with curatively treated basal and
squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- Serious, non healing wound, ulcer, or bone fracture.
- Evidence of any other disease, metabolic dysfunction, physical examination finding or
laboratory finding giving reasonable suspicion of a disease or condition that puts
the patient at high risk for treatment-related complications.
- Pregnancy or lactation
- Fertile women (< 2 years after last menstruation) and men of childbearing potential
not willing to use effective means of contraception.
Prior systemic administration of cetuximab or other anti-EGFR agent is not an exclusion
criterion.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Colorectal Cancer
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Hepatic Lesions
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Liver Metastases
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Intervention(s)
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Drug: IV cetuximab
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Drug: HAI chronomodulated chemotherapy
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Drug: HAI conventional chemotherapy
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Primary Outcome(s)
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Incidence of complete macroscopic resections (R0+R1) of unresectable liver metastases following chemotherapy.
[Time Frame: evaluation every 6th week up to 18 weeks]
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Secondary Outcome(s)
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The per-operative and post-operative complications associated to liver surgery
[Time Frame: continuous up to 3 months following surgery]
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The rate and site(s) of relapse in the resected patients throughout the 3-year span that follows hepatectomy
[Time Frame: every 2 month up to 3 years]
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The rate of adverse events
[Time Frame: continuous up to 30 days following end of treatment]
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The progression-free and the overall survival in the patients receiving at least 4 full courses of HAI therapy and in all the patients (intent to treat)
[Time Frame: every 2nd month up to 3 years]
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The relapse-free survival in the resected patients
[Time Frame: every 2nd month up to 3 years]
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The objective response rate
[Time Frame: every 6 weeks up to 18 weeks]
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Secondary ID(s)
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OPTILIV07
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EUDRACT number: 2007-004632-24
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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