Colorectal Neoplasms
Conditions
Brief summary
The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)
Interventions
DRUGBevacizumab
Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1
DRUGCapecitabine
Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4
DRUGIrinotecan
Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases) * Isolated (no extra-hepatic metastasis, primary tumor resected) * No access to curative hepatectomy (R0 resection foreseeable or not leaving less than 30% residual non-tumor liver normally vascularized), or requiring complex hepatectomy, very large (5 or more segments) and / or risked (class II CPP) * which at least one measurable by RECIST (\>2 cm, or \>1 cm if Computed tomography (CT) spiraled) * Or extra-hepatic disease of small size potentially accessible to a resection (one or two lung metastases, lymphadenopathy localized accessible to curative resection) * colon or rectal primary tumor : resected or asymptomatic * Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab * Age \>18 years \<75 years * Performance status WHO 0 or 1 * Life expectancy \>3 months * Bilirubin \<1.5 times the upper limit of normal (N), ASAT and ALAT \<5N, creatinine \<1.5 N neutrophils \>1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, hemoglobin \>9g/dL. Patients may be included even if they were transfused * CT (or MRI) reference for the measurement of metastases performed within 28 days before the first treatment cycle * Information of the patient or legal representative signing the informed consent * Affiliated to a social security system
Exclusion criteria
* Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage, major rectal syndrome) * Extra-hepatic metastases other than small size disease potentially accessible after resection * Grade 3-4 allergy to one of the treatment compounds * Two lines of prior chemotherapy. One line is allowed for metastatic disease but must have been started more than 6 months after completion of adjuvant treatment. * Participation during or within 30 days before study to another therapeutic trial with an experimental molecule * Concomitant cancer systemic treatment using immunotherapy, chemotherapy or hormone * Symptomatic CHD or myocardial infarction within 6 months prior entry into the study, cardiac arrhythmia uncontrolled despite treatment * Uncontrolled hypertension (blood pressure \>150/100 mm Hg despite hypertensive treatment) * Heart Failure \>Grade II of the New York Heart Association (NYHA) (class II-III-IV)severe renal failure * History and / or presence of bleeding disorders and/or thrombotic \<6 months * Uncontrolled Serious illness, uncontrolled active infection or other serious underlying condition which may prevent the patient to receive treatment * Pregnancy (or positive pregnancy test at baseline), lactation or no contraception effective for men or women of childbearing age * Occlusion or sub-bowel obstruction or history of inflammatory bowel disease * Other cancer within 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or skin basal-cell carcinoma properly treated) * Legal inability (persons deprived of liberty or under guardianship) * Inability to sign the consent or submit to medical test for geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency of treatment based on objective response rate | Every 9 weeks from the start to tumoral progression |
Secondary
| Measure | Time frame |
|---|---|
| Treatment toxicity based on NCI-CTC v4.0 | Every 3 weeks from the start to tumoral progression or toxicity preventing further processing |
| Progression Free Survival | Every 9 weeks form the start to tumoral progression |
| Hepatic metastasis resection rate | Assessed up 6 months after the end of treatment |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMichel Ducreux, MD-PhD
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed